Package No 1.
1. Reagent for the determination of total protein concentration in serum or blood plasma by burette. Reagent when opened stable at temperature. 2-80 C for at least 4 months. Prepackage max. 100 ml
2. Reagent for the determination of the concentration of albumin in serum or blood plasma by dye binding. Reagent when opened stable at temperature. 2-80 C for at least 4 months. Prepackage max. 100 ml
3. A total protein standard designed to calibrate routine photometric determinations of protein concentration in serum. Reagent when opened stable at temperature. 2-80 C for at least 4 months.
Prepackage max. 5 ml.
4. Albumin standard designed to calibrate routine photometric determinations of albumin concentrations in serum. Reagent when opened stable at temperature. 2-80 C for at least 4 months. Prepackage max. 5 ml
5. Control serum for routine control of the determination of concentrations of organic and inorganic constituents – normal level. Reagent when opened stable at temperature. 2-80 C for a minimum of 7 days. Prepackage max. 5 ml.
6. Control serum for routine control of the determination of concentrations of organic and inorganic constituents – pathological level. Reagent when opened stable at temperature. 2-80 C for a minimum of 7 days. Prepackage max. 5 ml.
Documents required in the tender:
— instructions for use in Polish in accordance with the provisions in force,
— declaration of conformity, notification to the database of the President of the URPLWMiPB pursuant to the Medical Devices Act of 20 May 2010 or notification to the President of the URPLWMiPB of the introduction of a device into the territory of the Republic of Poland pursuant to the Medical Devices Act of 20 May 2010.
Package No 2.
Platelet concentrate collection with MCS separator filter + code 994CF-E.
Documents required in the tender:
— instructions in Polish,
— declaration of conformity,
— CE document,
— notification to the database of the President of the URPLWMiPB pursuant to the Medical Devices Act of 20 May 2010 or notification to the President of the URPLWMiPB of the introduction of a device into the territory of the Republic of Poland pursuant to the Medical Devices Act of 20 May 2010.
Package No 3.
Papain reagent, standardised, with activity from 0,6 to 1,0. The titre and intensity of the agglutination expressed in the score should be at least 2 dilutions and twice the score in the colloid environment. The reagent must provide reproducible results, strong and sustained agglutination and shall be capable of eliminating non-specific reactions. Protein enzyme reagent causing changes within the cell membrane, which increases the reactivity of red blood cell antigens in serological reactions with antibodies, mainly from Rh, Kidd, Lewis, Ii. Reagent for use in immunohematology in all enzymatic methods, slide and tube tests. The application primarily allows the LEN test, the papaw test and the papaws of red blood cells to be performed. A period of validity of 11 months from the date of delivery. Packaging of not more than 5 ml, allowing daily, single use of an open portion.
Documents required in the tender:
— instructions for use in Polish,
— CE document,
— notification to the database of the President of the URPLWMiPB pursuant to the Medical Devices Act of 20 May 2010 or notification to the President of the URPLWMiPB of the introduction of a device into the territory of the Republic of Poland pursuant to the Medical Devices Act of 20 May 2010.
Package No 4.
A disposable needle scrubber for punching the skin with a depth of puncture of 2.4 mm.
Documents required in the tender:
— CE document,
— notification to the database of the President of the URPLWMiPB pursuant to the Medical Devices Act of 20 May 2010 or notification to the President of the URPLWMiPB of the introduction of a device into the territory of the Republic of Poland pursuant to the Medical Devices Act of 20 May 2010.
Package No 5.
1. Deglycerolisation kit type 235 for the ACP 215 apparatus.
2. 12 % NaCl solution, op. 250 ml – bag.
3. BIO-WASH 0.9 % NaCl + 0.2 % glucose, op. 2 000 ml – bag.
4. Enrichment solution e.g. SAGM, op. 350 ml – bag.
Documents required in the tender:
Declaration of conformity,
2. notification to the database of the President of the URPLWMiPB pursuant to the Medical Devices Act of 20 May 2010 or notification to the President of the URPLWMiPB concerning the introduction of a device into the territory of the Republic of Poland on the basis of the Medical Devices Act of 20.5.2010.
Period of validity from the date of delivery: item 1 – 24 months, item 2, 3 – 12 months, item 4 – 9 months.
Package No 6.
ACD (A) packed 250 ml – anticoagulant solution containing 1 000 ml: sodium citrate dihydrate: 22.0 g, citric acid monohydrate: 8.0 g., monohydrate glucose: 24.5 g, water for injection: up to 1 000 ml. Sterile, non-pyrogenic, non-toxic, colourless, pH 4,5 – 5,5, for infusion, infusion packed with a minimum of 1 port for injection.
Documents required in the tender:
Declaration of conformity.
2. notification to the database of the President of the URPLWMiPB pursuant to the Medical Devices Act of 20 May 2010 or notification to the President of the URPLWMiPB concerning the introduction of a device into the territory of the Republic of Poland on the basis of the Medical Devices Act of 20.5.2010.
A period of validity of at least 12 months from the date of delivery.
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