Reagents, Controls and Suppliers for Immunological Analyzer Cobas E601 ‘or The Equivalent’ and Cobas Emira ‘or The Equivalent’

Public Health Institute University Clinic for Clinical Biochemistry — Skopje

Part 1 Cardiac marker highly sensitive Troponin T for Cobas е 601 ‘Or Equivalent’;
Part 2 Virus marker HIV for Cobas е 601, ‘Or Equivalent’;
Part 3 Tumour markers NSE for Cobas e 601 ‘Or Equivalent’;
Part 4 Tumour marker PSA for Cobas е 601 ‘Or Equivalent’;
Part 5 Tumour marker CA 72-4 for Cobas е 601, ‘Or Equivalent’;
Part 6 Tumour marker Cyfra for Cobas е 601, ‘Or Equivalent’;
Part 7 Tumour marker AFP for Cobas е 601 ‘Or Equivalent’;
Part 8 Tumour marker CA 125 for Cobas е 601 ‘Or Equivalent’;
Part 9 Tumour marker CA 19-9 for Cobas е 601 ‘Or Equivalent’;
Part 10 Tumour marker CEA for Cobas е 601 ‘Or Equivalent’;
Part 11 Control for Tumour Marker for Cobas e 601 ‘Or Equivalent’;
Part 12 Vitamin B12 for Cobas е 601, ‘Or Equivalent’;
Part 13 Bone marker N-mid-Osteocalcin for Cobas е 601 ‘Or Equivalent’;
Part 14 Bone marker B-Cross Laps for Cobas е 601 ‘Or Equivalent’;
Part 15 Universal control sample in determining at least Folic acid, Osteocalcin, PTH, Vitamin D, Vitamin B12 for Cobas e 601 ‘Or Equivalent’;
Part 16 Concentrated cleaning agent for Cobas e 601 ‘Or Equivalent’;
Part 17 A means for dilution of samples — universal for Cobas e 601 ‘Or Equivalent’;
Part 18 Tumour marker CA 15-3 for Cobas е 601 ‘Or Equivalent’;
Part 19 Tumour marker S 100 for Cobas е 601 ‘Or Equivalent’;
Part 20 FT4 for Cobas е 601, ‘Or Equivalent’;
Part 21 TSH for Cobas е 601 ‘Or Equivalent’;
Part 22 Universal control sample for at least Cortizol, FT3, FT4, Total T3, Total T4 for Cobas e 601 ‘Or Equivalent’;
Part 23 Vitamin D for Cobas е 601 ‘Or Equivalent’;
Part 24 Folate for Cobas e 601 ‘Or Equivalent’;
Part 25 Testosterone for Cobas e 601 ‘Or Equivalent’;
Part 26 Anti-TPO for Cobas e 601 ‘Or Equivalent’;
Part 27 Means for diluting the sample of Troponin Т and TSH, for Cobas e 601 ‘Or Equivalent’;
Part 28 PTH, for Cobas е 601 ‘Or Equivalent’;
Part 29 Universal control for at least CEA, AFP, FT3, FT4, PSA, S100, Testosterone, T3, T4 Cobas e 601’ ‘Or Equivalent’;
Part 30 Tumour marker Free PSA ,‘Or Equivalent’ for Cobas е 601;
Part 31 Virus marker HBSAg ‘Or Equivalent’ for Cobas е 601
Part 32 Virus marker anti-HCV for Cobas е 601 ‘Or Equivalent’;
Part 33 A means for preparing a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days;
Part 34 A means for cleaning a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days;
Part 35 A means for cleaning — solution to reduce interference in measurement for Cobas e 601 ‘Or Equivalent’ package with min. 500ml;
Part 36 A means for cleaning the reagent needle Cobas е 601 ‘Or Equivalent’;
Part 37 Plastic tub for application cleaner for cleaning the reagent needle for Cobas е 601 ‘Or Equivalent’;
Part 38 Plastic tub for application of system reagents for preparation of the measuring cell for Cobas е 601 ‘Or Equivalent’;
Part 39 Consumables — earmarked tentacles for pipetting serum with volume of 5 μl-100 μl package with min. 500;
Part 40 A means for preparing the measuring cell package with min. volume of 380 ml for Cobas e 601 or equivalent with stability in the machine for 3 days;
Part 41 A means for cleaning the measuring cell for Cobas e 601 ‘Or Equivalent’ package with min. volume of 380ml with stability in the machine for 3 days;
Part 42 Detergent for Cobas e 601 ‘Or Equivalent’;
Part 43 Tumour marker HЕ-4 for Cobas e 601 ‘Or Equivalent’;
Part 44 Reagent kit for the determination of angiotensin converting enzyme (ACE) a colorimetric kinetic method of Cobas Emira ‘Or Equivalent’;
Part 45 Plastic cuvettes for sample — serum with dimensions of minimum 17mmX38mm and volume 2ml applicative for Cobas е 601 ‘Or Equivalent’.

Рок

Рокот за прием на понудите беше 2016-08-29. Набавката беше објавена на 2016-07-26.

Кој?

• Public Health Institute University Clinic for Clinical Biochemistry — Skopje

Што?

• Медицинска опрема, фармацевтски производи и производи за лична нега

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2016-07-26	Оглас за договор

Оглас за договор (2016-07-26)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицинска опрема, фармацевтски производи и производи за лична нега 📦

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за еден или повеќе делови
Критериуми за доделување
Не е наведено

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Друго
Име на органот кој доделува: Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Поштенска адреса: Vodnjanska 17
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Е-пошта: jzuklinickabiohemija@gmail.com 📧
Телефон: +389 23125370 📞

Референца
Датуми
Датум на испраќање: 2016-07-26 📅
Рок за поднесување: 2016-08-29 📅
Датум на објавување: 2016-07-29 📅
Идентификатори
Број на огласот: 2016/S 145-262791
OJ-S издание: 145

Предмет
Опсег на набавката
Краток опис:

Part 1 Cardiac marker highly sensitive Troponin T for Cobas е 601 ‘Or Equivalent’;

Part 2 Virus marker HIV for Cobas е 601, ‘Or Equivalent’;

Part 3 Tumour markers NSE for Cobas e 601 ‘Or Equivalent’;

Part 4 Tumour marker PSA for Cobas е 601 ‘Or Equivalent’;

Part 5 Tumour marker CA 72-4 for Cobas е 601, ‘Or Equivalent’;

Part 6 Tumour marker Cyfra for Cobas е 601, ‘Or Equivalent’;

Part 7 Tumour marker AFP for Cobas е 601 ‘Or Equivalent’;

Part 8 Tumour marker CA 125 for Cobas е 601 ‘Or Equivalent’;

Part 9 Tumour marker CA 19-9 for Cobas е 601 ‘Or Equivalent’;

Part 10 Tumour marker CEA for Cobas е 601 ‘Or Equivalent’;

Part 11 Control for Tumour Marker for Cobas e 601 ‘Or Equivalent’;

Part 12 Vitamin B12 for Cobas е 601, ‘Or Equivalent’;

Part 13 Bone marker N-mid-Osteocalcin for Cobas е 601 ‘Or Equivalent’;

Part 14 Bone marker B-Cross Laps for Cobas е 601 ‘Or Equivalent’;

Part 15 Universal control sample in determining at least Folic acid, Osteocalcin, PTH, Vitamin D, Vitamin B12 for Cobas e 601 ‘Or Equivalent’;

Part 16 Concentrated cleaning agent for Cobas e 601 ‘Or Equivalent’;

Part 17 A means for dilution of samples — universal for Cobas e 601 ‘Or Equivalent’;

Part 18 Tumour marker CA 15-3 for Cobas е 601 ‘Or Equivalent’;

Part 19 Tumour marker S 100 for Cobas е 601 ‘Or Equivalent’;

Part 20 FT4 for Cobas е 601, ‘Or Equivalent’;

Part 21 TSH for Cobas е 601 ‘Or Equivalent’;

Part 22 Universal control sample for at least Cortizol, FT3, FT4, Total T3, Total T4 for Cobas e 601 ‘Or Equivalent’;

Part 23 Vitamin D for Cobas е 601 ‘Or Equivalent’;

Part 24 Folate for Cobas e 601 ‘Or Equivalent’;

Part 25 Testosterone for Cobas e 601 ‘Or Equivalent’;

Part 26 Anti-TPO for Cobas e 601 ‘Or Equivalent’;

Part 27 Means for diluting the sample of Troponin Т and TSH, for Cobas e 601 ‘Or Equivalent’;

Part 28 PTH, for Cobas е 601 ‘Or Equivalent’;

Part 29 Universal control for at least CEA, AFP, FT3, FT4, PSA, S100, Testosterone, T3, T4 Cobas e 601’ ‘Or Equivalent’;

Part 30 Tumour marker Free PSA ,‘Or Equivalent’ for Cobas е 601;

Part 31 Virus marker HBSAg ‘Or Equivalent’ for Cobas е 601

Part 32 Virus marker anti-HCV for Cobas е 601 ‘Or Equivalent’;

Part 33 A means for preparing a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days;

Part 34 A means for cleaning a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days;

Part 35 A means for cleaning — solution to reduce interference in measurement for Cobas e 601 ‘Or Equivalent’ package with min. 500ml;

Part 36 A means for cleaning the reagent needle Cobas е 601 ‘Or Equivalent’;

Part 37 Plastic tub for application cleaner for cleaning the reagent needle for Cobas е 601 ‘Or Equivalent’;

Part 38 Plastic tub for application of system reagents for preparation of the measuring cell for Cobas е 601 ‘Or Equivalent’;

Part 39 Consumables — earmarked tentacles for pipetting serum with volume of 5 μl-100 μl package with min. 500;

Part 40 A means for preparing the measuring cell package with min. volume of 380 ml for Cobas e 601 or equivalent with stability in the machine for 3 days;

Part 41 A means for cleaning the measuring cell for Cobas e 601 ‘Or Equivalent’ package with min. volume of 380ml with stability in the machine for 3 days;

Part 42 Detergent for Cobas e 601 ‘Or Equivalent’;

Part 43 Tumour marker HЕ-4 for Cobas e 601 ‘Or Equivalent’;

Part 44 Reagent kit for the determination of angiotensin converting enzyme (ACE) a colorimetric kinetic method of Cobas Emira ‘Or Equivalent’;

Part 45 Plastic cuvettes for sample — serum with dimensions of minimum 17mmX38mm and volume 2ml applicative for Cobas е 601 ‘Or Equivalent’.

Број на дел: 1
Наслов на делот: Part 1 Cardiac marker highly sensitive Troponin T for Cobas е 601 ‘Or Equivalent’
Краток опис:

Part 1 Cardiac marker highly sensitive Troponin T for Cobas е 601 ‘Or Equivalent’.

Количина или опсег: 1. Solutions for calibration of highly sensitive Troponin T for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 18 ng/L and top limit ≥ 4200 ng/L;2. Control sample of highly sensitive Troponin T for Cobas e 601 ‘Or Equivalent’;3. Reagent for the determination of highly sensitive Troponin T in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 3 ng/L top limit ≥ 10 000 ng/L, package with min. 100 tests.

1. Solutions for calibration of highly sensitive Troponin T for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 18 ng/L and top limit ≥ 4200 ng/L;

2. Control sample of highly sensitive Troponin T for Cobas e 601 ‘Or Equivalent’;

3. Reagent for the determination of highly sensitive Troponin T in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 3 ng/L top limit ≥ 10 000 ng/L, package with min. 100 tests.

Број на дел: 2
Наслов на делот: Part 2 Virus marker HIV for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 2 Virus marker HIV for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for the determination of HIV virus (combined determining of antigen and antibody) in serum for Cobas e 601 ‘Or Equivalent’ qualitative test, package with min. 100 tests;2. Control sample for HIV (combined determining of antigen and antibody) for Cobas e 601 ‘Or Equivalent’.

1. Reagent for the determination of HIV virus (combined determining of antigen and antibody) in serum for Cobas e 601 ‘Or Equivalent’ qualitative test, package with min. 100 tests;

2. Control sample for HIV (combined determining of antigen and antibody) for Cobas e 601 ‘Or Equivalent’.

Број на дел: 3
Наслов на делот: Part 3 Tumour markers NSE for Cobas e 601 ‘Or Equivalent’
Краток опис: Part 3 Tumour markers NSE for Cobas e 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour markers NSE for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,5 ng/ml and top limit ≥ 50 ng/ml;2. Reagent for the determination of tumour marker NSE in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,05 ng/ml top limit ≥ 370 ng/ml package with min. 100 tests.

1. Solutions for calibration of tumour markers NSE for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,5 ng/ml and top limit ≥ 50 ng/ml;

2. Reagent for the determination of tumour marker NSE in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,05 ng/ml top limit ≥ 370 ng/ml package with min. 100 tests.

Број на дел: 4
Наслов на делот: Part 4 Tumour marker PSA for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 4 Tumour marker PSA for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour marker PSA FOR Cobas e 601 ‘Or Equivalent’ with bottom limit 0 ng/ml and top limit ≥ 60 ng/ml;2. Reagent for the determination of tumour marker PSA in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,003 ng/ml top limit ≥ 100 ng/ml package with min. 100 tests.

1. Solutions for calibration of tumour marker PSA FOR Cobas e 601 ‘Or Equivalent’ with bottom limit 0 ng/ml and top limit ≥ 60 ng/ml;

2. Reagent for the determination of tumour marker PSA in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,003 ng/ml top limit ≥ 100 ng/ml package with min. 100 tests.

Број на дел: 5
Наслов на делот: Part 5 Tumour marker CA 72-4 for Cobas е 601, ‘Or Equivalent’
Краток опис: Part 5 Tumour marker CA 72-4 for Cobas е 601, ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour marker CA 72-4 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 1 U/ml and top limit ≥ 70 U/ml;2. Reagent for determining tumour marker CA 72-4 in serum compatible to an immune analizator for Cobas е 601 ‘Or Equivalent’, with measuring range ≤ 0,2 U/ml top limit ≥ 300 U/ml package with minimum 100 tests.

1. Solutions for calibration of tumour marker CA 72-4 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 1 U/ml and top limit ≥ 70 U/ml;

2. Reagent for determining tumour marker CA 72-4 in serum compatible to an immune analizator for Cobas е 601 ‘Or Equivalent’, with measuring range ≤ 0,2 U/ml top limit ≥ 300 U/ml package with minimum 100 tests.

Број на дел: 6
Наслов на делот: Part 6 Tumour marker Cyfra for Cobas е601, ‘Or Equivalent’
Краток опис: Part 6 Tumour marker Cyfra for Cobas е601, ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour marker Cyfra 21-1 for Cobas e 601 ‘Or Equivalent’, with bottom limit 0 ng/ml and top limit ≥ 50 ng/ml;2. Reagent for the determination of tumour marker Cyfra 21-1 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,1 ng/ml top limit ≥ 500 ng/ml package with min. 100 tests.

1. Solutions for calibration of tumour marker Cyfra 21-1 for Cobas e 601 ‘Or Equivalent’, with bottom limit 0 ng/ml and top limit ≥ 50 ng/ml;

2. Reagent for the determination of tumour marker Cyfra 21-1 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,1 ng/ml top limit ≥ 500 ng/ml package with min. 100 tests.

Број на дел: 7
Наслов на делот: Part 7 Tumour marker AFP for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 7 Tumour marker AFP for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour marker AFP for Cobas e 601‘Or Equivalent’ with bottom limit ≤5 IU/ml and top limit ≥ 50 IU/ml;2. Reagent for determining tumour marker AFP in serum for Cobas e 601‘Or Equivalent’ with measuring range ≤ 0,5 IU/ml top limit ≥ 1 000 IU/ml package with min. 100 tests.

1. Solutions for calibration of tumour marker AFP for Cobas e 601‘Or Equivalent’ with bottom limit ≤5 IU/ml and top limit ≥ 50 IU/ml;

2. Reagent for determining tumour marker AFP in serum for Cobas e 601‘Or Equivalent’ with measuring range ≤ 0,5 IU/ml top limit ≥ 1 000 IU/ml package with min. 100 tests.

Број на дел: 8
Наслов на делот: Part 8 Tumour marker CA 125 for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 8 Tumour marker CA 125 for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour marker CA 125 for Cobas e 601 ‘Or Equivalent’ with bottom limit 0 U/ml and top limit ≥ 500 U/ml;2. Reagent for determining tumour marker CA 125 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,6 U/ml top limit ≥ 5 000 U/ml, package with min. 100 tests.

1. Solutions for calibration of tumour marker CA 125 for Cobas e 601 ‘Or Equivalent’ with bottom limit 0 U/ml and top limit ≥ 500 U/ml;

2. Reagent for determining tumour marker CA 125 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,6 U/ml top limit ≥ 5 000 U/ml, package with min. 100 tests.

Број на дел: 9
Наслов на делот: Part 9 Tumour marker CA 19-9 for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 9 Tumour marker CA 19-9 for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour marker CA 19-9 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 20 U/ml and top limit ≥ 250 U/ml;2. Reagent for determining tumour marker CA 19-9 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,600 U/ml top limit ≥ 1 000 U/ml package with min. 100 tests.

1. Solutions for calibration of tumour marker CA 19-9 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 20 U/ml and top limit ≥ 250 U/ml;

2. Reagent for determining tumour marker CA 19-9 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,600 U/ml top limit ≥ 1 000 U/ml package with min. 100 tests.

Број на дел: 10
Наслов на делот: Part 10 Tumour marker CEA for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 10 Tumour marker CEA for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of tumour marker CEA for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 5 ng/ml and top limit ≥ 50 ng/ml;2. Reagent for determining tumour marker CEA in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,200 ng/ml top limit ≥ 1 000 ng/ml package with min. 100 tests.

1. Solutions for calibration of tumour marker CEA for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 5 ng/ml and top limit ≥ 50 ng/ml;

2. Reagent for determining tumour marker CEA in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,200 ng/ml top limit ≥ 1 000 ng/ml package with min. 100 tests.

Број на дел: 11
Наслов на делот: Part 11 Control for Tumour Marker for Cobas e 601 ‘Or Equivalent’
Краток опис: Part 11 Control for Tumour Marker for Cobas e 601 ‘Or Equivalent’.
Количина или опсег: 1. Control sample in determining at least CEA, PSA, CA 125, CA 15-3, Cyfra 21-1, CA 72-4, NSE for Cobas e 601 ‘Or Equivalent’.
Број на дел: 12
Наслов на делот: Part 12 Vitamin B12 for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 12 Vitamin B12 for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of Vitamin B12 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 250 pg/ml and top limit ≥1 500 pg/ml;2. Reagent for determination of Vitamin B12 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤30 pg/ml top limit ≥ 2 000 pg/ml package with min. 100 tests.

1. Solutions for calibration of Vitamin B12 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 250 pg/ml and top limit ≥1 500 pg/ml;

2. Reagent for determination of Vitamin B12 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤30 pg/ml top limit ≥ 2 000 pg/ml package with min. 100 tests.

Број на дел: 13
Наслов на делот: Part 13 Bone marker N-Mid Osteocalcin for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 13 Bone marker N-Mid Osteocalcin for Cobas е 601‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of bone marker N-Mid Osteocalcin for Cobas e 601 ‘Or Equivalent’ with bottom limit 0 ng/ml and top limit ≥ 280 ng/ml;2. Reagent for determination of bone marker N-Mid Osteocalcin in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,5 ng/ml top limit ≥ 300 ng/ml package with min. 100 tests.

1. Solutions for calibration of bone marker N-Mid Osteocalcin for Cobas e 601 ‘Or Equivalent’ with bottom limit 0 ng/ml and top limit ≥ 280 ng/ml;

2. Reagent for determination of bone marker N-Mid Osteocalcin in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,5 ng/ml top limit ≥ 300 ng/ml package with min. 100 tests.

Број на дел: 14
Наслов на делот: Part 14 Bone marker B-Cross Laps for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 14 Bone marker B-Cross Laps for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Solutions for calibration of bone marker B-Cross Laps for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,05 ng/ml and top limit ≥2 ng/ml;2. Reagent for determination of bone marker B-Cross Laps in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,01 ng/ml top limit ≥ 60 ng/ml package with min. 100 tests.

1. Solutions for calibration of bone marker B-Cross Laps for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,05 ng/ml and top limit ≥2 ng/ml;

2. Reagent for determination of bone marker B-Cross Laps in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,01 ng/ml top limit ≥ 60 ng/ml package with min. 100 tests.

Број на дел: 15
Наслов на делот: Part 15 Universal control sample in determining at least folic acid, Osteocalcin, PTH, Vitamin D, Vitamin B12 for Cobas e 601 ‘Or Equivalent’
Краток опис:

Part 15 Universal control sample in determining at least folic acid, Osteocalcin, PTH, Vitamin D, Vitamin B12 for Cobas e 601 ‘Or Equivalent’.

Број на дел: 16
Наслов на делот: Part 16 Concentrated cleaning agent for Cobas e 601 ‘Or Equivalent’
Краток опис: Part 16 Concentrated cleaning agent for Cobas e 601 ‘Or Equivalent’.
Број на дел: 17
Наслов на делот: Part 17 A means for dilution of samples — universal for Cobas e 601 ‘Or Equivalent’
Краток опис:

Part 17 A means for dilution of samples — universal for Cobas e601 ‘Or Equivalent’.

Број на дел: 18
Наслов на делот: Part 18 Tumour marker CA 15-3 for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 18 Tumour marker CA 15-3 for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determining tumour marker CA 15-3 in serum for Cobas e 601‘Or Equivalent’ with measuring range ≤ 1 U/ml top limit ≥ 300 U/ml package with min. 100 tests;2. Solutions for calibration of tumour marker CA 15-3 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 15 U/ml and top limit ≥100 U/ml.

1. Reagent for determining tumour marker CA 15-3 in serum for Cobas e 601‘Or Equivalent’ with measuring range ≤ 1 U/ml top limit ≥ 300 U/ml package with min. 100 tests;

2. Solutions for calibration of tumour marker CA 15-3 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 15 U/ml and top limit ≥100 U/ml.

Број на дел: 19
Наслов на делот: Part 19 Tumour marker S 100 for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 19 Tumour marker S 100 for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determining tumour marker S100 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,005 μg/L top limit ≥ 39 μg/L package with min. 100 tests;2. Solutions for calibration of tumour marker S100 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤0,2 ng/ml and top limit ≥ 2,0 ng/ml.

1. Reagent for determining tumour marker S100 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,005 μg/L top limit ≥ 39 μg/L package with min. 100 tests;

2. Solutions for calibration of tumour marker S100 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤0,2 ng/ml and top limit ≥ 2,0 ng/ml.

Број на дел: 20
Наслов на делот: Part 20 FT4 for Cobas е 601, ‘Or Equivalent’
Краток опис: Part 20 FT4 for Cobas е 601, ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of hormone FT4 (free fraction of thyroxine) in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,3 pmol/L top limit ≥ 100 pmol/L package with min. 200 tests;2. Solutions for calibration of hormone FT4 (free fraction of thyroxine) for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 10 pmol/L and top limit ≥ 45 pmol/L.

1. Reagent for determination of hormone FT4 (free fraction of thyroxine) in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,3 pmol/L top limit ≥ 100 pmol/L package with min. 200 tests;

2. Solutions for calibration of hormone FT4 (free fraction of thyroxine) for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 10 pmol/L and top limit ≥ 45 pmol/L.

Број на дел: 21
Наслов на делот: Part 21 TSH for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 21 TSH for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of hormone TSH in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,005 μIU/ml top limit ≥ 100 μIU/ml, package with min. 200 tests;2. Solutions for calibration of hormone TSH for Cobas e 601 ‘Or Equivalent’ with bottom limit 0 μIU/ml and top limit ≥ 1,5 μIU/ml.

1. Reagent for determination of hormone TSH in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,005 μIU/ml top limit ≥ 100 μIU/ml, package with min. 200 tests;

2. Solutions for calibration of hormone TSH for Cobas e 601 ‘Or Equivalent’ with bottom limit 0 μIU/ml and top limit ≥ 1,5 μIU/ml.

Број на дел: 22
Наслов на делот: Part 22 Universal control sample for at least Cortizol, FT3, FT4, Total T3, Total T4 for Cobas e 601 ‘Or Equivalent’
Краток опис:

Part 22 Universal control sample for at least Cortizol, FT3, FT4, Total T3, Total T4 for Cobas e 601 ‘Or Equivalent’.

Број на дел: 23
Наслов на делот: Part 23 Vitamin D for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 23 Vitamin D for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of Vitamin D in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 3 ng/ml top limit ≥ 70 ng/ml package with min. 100 tests;2. Solutions for calibration of Vitamin D for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 2 ng/ml and top limit of ≥45 ng/ml.

1. Reagent for determination of Vitamin D in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 3 ng/ml top limit ≥ 70 ng/ml package with min. 100 tests;

2. Solutions for calibration of Vitamin D for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 2 ng/ml and top limit of ≥45 ng/ml.

Број на дел: 24
Наслов на делот: Part 24 Folate for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 24 Folate for Cobas е 601‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of Folate in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,6 ng/ml top limit ≥ 60 ng/ml package with min. 100 tests;2. Solutions for calibration of Folate for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,6 ng/ml and top limit ≥7 ng/ml.

1. Reagent for determination of Folate in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,6 ng/ml top limit ≥ 60 ng/ml package with min. 100 tests;

2. Solutions for calibration of Folate for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,6 ng/ml and top limit ≥7 ng/ml.

Број на дел: 25
Наслов на делот: Part 25 Testosterone for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 25 Testosterone for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of Testosterone in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,025 ng/ml top limit ≥ 15 ng/ml package with min. 100 tests;2. Solutions for calibration of Testosterone for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,4 ng/ml and top limit ≥11,5 ng/ml.

1. Reagent for determination of Testosterone in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 0,025 ng/ml top limit ≥ 15 ng/ml package with min. 100 tests;

2. Solutions for calibration of Testosterone for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,4 ng/ml and top limit ≥11,5 ng/ml.

Број на дел: 26
Наслов на делот: Part 26 Anti-TPO for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 26 Anti-TPO for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of thyroid antibody Anti-TPO in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 5 IU/L top limit ≥ 600 IU/L package with min. 100 tests;2. Solutions for calibration of thyroid antibody Anti-TPO for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 5 IU/L top limit ≥ 600 IU/L.

1. Reagent for determination of thyroid antibody Anti-TPO in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 5 IU/L top limit ≥ 600 IU/L package with min. 100 tests;

2. Solutions for calibration of thyroid antibody Anti-TPO for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 5 IU/L top limit ≥ 600 IU/L.

Број на дел: 27
Наслов на делот: Part 27 Means for diluting the sample of Troponin Т and TSH, for Cobas e 601 ‘Or Equivalent’
Краток опис:

Part 27 Means for diluting the sample of Troponin Т and TSH, for Cobas e 601 ‘Or Equivalent’.

Број на дел: 28
Наслов на делот: Part 28 PTH, for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 28 PTH, for Cobas е 601‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of hormone PTH in serum for Cobas e 601 ‘Or Equivalent’ with measuring range from ≤ 0,127 pmol/L top limit ≥ 530 pmol/L package with min. 100 tests;2. Solutions for calibration of hormone PTH for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,005 pmol/L and top limit ≥ 477 pmol/L.

1. Reagent for determination of hormone PTH in serum for Cobas e 601 ‘Or Equivalent’ with measuring range from ≤ 0,127 pmol/L top limit ≥ 530 pmol/L package with min. 100 tests;

2. Solutions for calibration of hormone PTH for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 0,005 pmol/L and top limit ≥ 477 pmol/L.

Број на дел: 29
Наслов на делот: Part 29 Universal control for at least CEA, AFP, FT3, FT4, PSA, S100, Testosterone, T3, T4 Cobas E601 ‘Or Equivalent’
Краток опис:

Part 29 Universal control for at least CEA, AFP, FT3, FT4, PSA, S100, Testosterone, T3, T4 Cobas e 601 ‘Or Equivalent’.

Број на дел: 30
Наслов на делот: Part 30 Tumour marker Free PSA ‘Or Equivalent’ for Cobas е 601
Краток опис: Part 30 Tumour marker Free PSA ‘Or Equivalent’ for Cobas е 601.
Количина или опсег: 1. Reagent for determining tumour marker Free PSA (free fraction of PSA) in serum for Cobas eu601 ‘Or Equivalent’ with measuring range ≤ 0,010 ng/ml top limit ≥ 50 ng/ml package with min.100 tests;2. Solutions for calibration of tumour marker Free PSA (free fraction of PSA) for Cobas e 601 ‘Or Equivalent’ with bottom limit of detection ≤ 0,10 ng/ml and top limit of detection ≥20 ng/ml.

1. Reagent for determining tumour marker Free PSA (free fraction of PSA) in serum for Cobas eu601 ‘Or Equivalent’ with measuring range ≤ 0,010 ng/ml top limit ≥ 50 ng/ml package with min.100 tests;

2. Solutions for calibration of tumour marker Free PSA (free fraction of PSA) for Cobas e 601 ‘Or Equivalent’ with bottom limit of detection ≤ 0,10 ng/ml and top limit of detection ≥20 ng/ml.

Број на дел: 31
Наслов на делот: Part 31 Virus marker HBSAg ‘Or Equivalent’ for Cobas е 601
Краток опис: Part 31 Virus marker HBSAg ‘Or Equivalent’ for Cobas е 601.
Количина или опсег: 1. Reagent for determination of virus marker HBSAg in serum for Cobas e 601 ‘Or Equivalent’ qualitative test, package with min.100 tests;2. Control sample for virus marker HBSAg for Cobas e 601 ‘Or Equivalent’.

1. Reagent for determination of virus marker HBSAg in serum for Cobas e 601 ‘Or Equivalent’ qualitative test, package with min.100 tests;

2. Control sample for virus marker HBSAg for Cobas e 601 ‘Or Equivalent’.

Број на дел: 32
Наслов на делот: Part 32 Virus marker Anti-HCV for Cobas е 601 ‘Or Equivalent’
Краток опис: Part 32 Virus marker Anti-HCV for Cobas е 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of virus marker Anti-HCV in serum for Cobas e 601 ‘Or Equivalent’ qualitative test, package with min.100 tests;2. Control sample for virus marker Anti-HCV for Cobas e 601 ‘Or Equivalent’.

1. Reagent for determination of virus marker Anti-HCV in serum for Cobas e 601 ‘Or Equivalent’ qualitative test, package with min.100 tests;

2. Control sample for virus marker Anti-HCV for Cobas e 601 ‘Or Equivalent’.

Број на дел: 33
Наслов на делот: Part 33 A means for preparing a measurement cell with min. volume of 2L for Cobas e 601 or equivalent with stability in the machine for 5 days
Краток опис:

Part 33 A means for preparing a measurement cell with min. volume of 2L for Cobas e 601 or equivalent with stability in the machine for 5 days.

Број на дел: 34
Наслов на делот: Part 34 A means for cleaning a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days
Краток опис:

Part 34 A means for cleaning a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days.

Број на дел: 35
Наслов на делот: Part 35 A means for cleaning — solution to reduce interference in measurement for Cobas e 601 ‘Or Equivalent’ package with min. 500ml
Краток опис:

Part 35 A means for cleaning — solution to reduce interference in measurement for Cobas e 601 ‘Or Equivalent’ package with min. 500ml.

Број на дел: 36
Наслов на делот: Part 36 A means for cleaning the reagent needle Cobas е 601 ‘Or Equivalent’
Краток опис: Part 36 A means for cleaning the reagent needle Cobas е 601 ‘Or Equivalent’.
Број на дел: 37
Наслов на делот: Part 37 Plastic tub for application cleaner for cleaning the reagent needle for Cobas е 601 ‘Or Equivalent’
Краток опис:

Part 37 Plastic tub for application cleaner for cleaning the reagent needle for Cobas е 601 ‘Or Equivalent’.

Број на дел: 38
Наслов на делот: Part 38 Plastic tub for application of system reagents for preparation of the measuring cell for Cobas е 601 ‘Or Equivalent’
Краток опис:

Part 38 Plastic tub for application of system reagents for preparation of the measuring cell for Cobas е 601 ‘Or Equivalent’.

Број на дел: 39
Наслов на делот: Part 39 Consumables — earmarked tentacles for pipetting serum with volume of 5 μl-100 μl package with min. 500
Краток опис:

Part 39 Consumables — earmarked tentacles for pipetting serum with volume of 5 μl-100 μl package with min. 500.

Број на дел: 40
Наслов на делот: Part 40 A means for preparing the measuring cell package with min. volume of 380 ml for Cobas e 601 or equivalent with stability in the machine for 3 days
Краток опис:

Part 40 A means for preparing the measuring cell package with min. volume of 380 ml for Cobas e 601 or equivalent with stability in the machine for 3 days.

Број на дел: 41
Наслов на делот: Part 41 A means for cleaning the measuring cell for Cobas e 601 ‘Or Equivalent’ package with min. volume of 380ml with stability in the machine for 3 days
Краток опис:

Part 41 A means for cleaning the measuring cell for Cobas e 601 ‘Or Equivalent’ package with min. volume of 380ml with stability in the machine for 3 days.

Број на дел: 42
Наслов на делот: Part 42 Detergent for Cobas e 601 ‘Or Equivalent’
Краток опис: Part 42 Detergent for Cobas e 601 ‘Or Equivalent’.
Број на дел: 43
Наслов на делот: Part 43 Tumour marker HЕ-4 for Cobas e 601 ‘Or Equivalent’
Краток опис: Part 43 Tumour marker HЕ-4 for Cobas e 601 ‘Or Equivalent’.
Количина или опсег: 1. Reagent for determination of tumour marker HЕ-4 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 15 pmol/L top limit ≥ 1 500 pmol/L package with min. 100 tests;2. Solutions for calibration of HЕ-4 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 5pmol/L and top limit ≥ 200 pmol/L;3. Control sample for marker HE-4 for Cobas e 601 ‘Or Equivalent’.

1. Reagent for determination of tumour marker HЕ-4 in serum for Cobas e 601 ‘Or Equivalent’ with measuring range ≤ 15 pmol/L top limit ≥ 1 500 pmol/L package with min. 100 tests;

2. Solutions for calibration of HЕ-4 for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 5pmol/L and top limit ≥ 200 pmol/L;

3. Control sample for marker HE-4 for Cobas e 601 ‘Or Equivalent’.

Број на дел: 44
Наслов на делот: Part 44 Reagent kit for the determination of angiotensin converting enzyme (ACE) a colorimetric kinetic method of Cobas Emira ‘Or Equivalent’
Краток опис:

Part 44 Reagent kit for the determination of angiotensin converting enzyme (ACE) a colorimetric kinetic method of Cobas Emira ‘Or Equivalent’.

Број на дел: 45
Наслов на делот: Part 45 Plastic cuvettes for sample — serum with dimensions of minimum 17mmX38mm and volume 2ml applicative for Cobas е 601 ‘Or Equivalent’

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:

— Document for registered activity — DRD form or certificate of registered activity;

— Decision for wholesale trade with medical supplies under the Law on Medicines and Medical Appliances;

— A statement by the economic operator that it has not been imposed a legally valid Court decision for participation in criminal organization, corruption, fraud or money laundering for the last 5 years;

— A certificate by a competent authority that a…

… bankruptcy procedure has not been initiated;

… liquidation procedure has not been initiated;

— A certificate by a competent authority from the country where that economic operator is registered for paid taxes, contributions and other public duties;

— A certificate by the Register of Sentences for Committed Crimes of Legal Entities that a secondary sentence…

… prohibition on participation in open call procedures, awarding public procurement contracts and contracts for public-private partnership, has not been imposed;

… temporary or permanent prohibition on performing a certain activity has not been imposed; and,

— A certificate that a misdemeanour sanction resulting in prohibition for practising profession, performing activity or duty, i.e. temporary prohibition for performing a particular activity has not been imposed by a legally valid Court decision.

Техничка и професионална способност:

For registered medical appliances:

— For the offered goods the economic operator shall have an Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances.

For unregistered medical appliances:

— For the offered goods the economic operator shall have a document allowing import (An Approval for Interventional Import) according to the Law on Medicines and Medical Appliances.

Минимално ниво(а) на стандарди:

For registered medical appliances:

— Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances.

For unregistered medical appliances:

— Import License (Approval for Intervention Import) under the Law on Medicines and Medical Appliances.

Извршување на договорот
Потребни депозити и гаранции:

A condition for signing a contract with the most favourable economic operator is to provide a bank guarantee by the tenderer who is selected as the most favourable as well as for implementation of the contract in a quality manner in amount of 5 % of the value of the contract. VAT excluded.

Постапка
Датум на отворање на понудите: 2016-08-29 📅
Информации за овластени лица и постапка за отворање: Any person with authorisation letter from his/her.
Јазици
Други јазици: Macedonian.

Договорен орган
Идентитет
Друг вид договорен орган: Other

Дополнителни информации
Тело за преглед
Име: State Commission on Public Procurement
Поштенска адреса: Bul. Ilinden 63a
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Е-пошта: dkzjn@gs.gov.mk 📧
Телефон: +389 23251251 📞
Факс: +389 23251250 📠
Извор: OJS 2016/S 145-262791 (2016-07-26)

Нови набавки во поврзани категории 🆕

Медицинска опрема, фармацевтски производи и производи за лична нега (19 нови набавки)