IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Product name:
HIV Ag/Ab Combination
Product code
Type of Immunoassay/ Analyte:
An enzyme immunoassay for the simultaneous qualitative detection of Human Immunodeficiency Virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group O) and HIV type 2 (HIV-2) in human serum of plasma.
Name of reagent
Product code
Specimen of sample type to be used: Serum of plasma
Accessories:
Coated well, Sample diluent, Conjugate, Conjugate Diluent, Anti-HIV-1 Positive Control, Anti-HIV-2 Positive Control, HIV-1 p24 Positive Control, Negative Control, Substrate Diluent, Substrate Concentrate, Wash Fluid
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Name of instruments of component if applicable:
Product code
Population: All population
Packaging and labelling:
Pack size: 30, 50s, 100s test pouch
Cartridge guide
Note: Pack Sizes are not limited to the ones indicated above. It will be considered bigger of smaller ones according to the UNFPA Needs and products availability.
Shelf life: 24 /36 months
Instructions for use
Transport Storage and operating Temperature:
Storage conditions: The test kit should be stored at 2-8 °C. (of as per stability studies guidelines)
Do not freeze
Transportation conditions
Operating Temperature: use at 15-25 within 10 minutes (of as IFU guidelines)
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/ 745 US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Note: CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking
Classification: Classified under EU MDR 2017/745 as Class I device
Environmental requirements: Rohs compliance
Product name:
HIV Ag/Ab Combination
Product code
Type of Immunoassay/ Analyte:
An enzyme immunoassay for the simultaneous qualitative detection of Human Immunodeficiency Virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group O) and HIV type 2 (HIV-2) in human serum of plasma.
Name of reagent
Product code
Specimen of sample type to be used: Serum of plasma
Accessories:
Coated well, Sample diluent, Conjugate, Conjugate Diluent, Anti-HIV-1 Positive Control, Anti-HIV-2 Positive Control, HIV-1 p24 Positive Control, Negative Control, Substrate Diluent, Substrate Concentrate, Wash Fluid
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Name of instruments of component if applicable:
Product code
Population: All population
Packaging and labelling:
Pack size: 30, 50s, 100s test pouch
Cartridge guide
Note: Pack Sizes are not limited to the ones indicated above. It will be considered bigger of smaller ones according to the UNFPA Needs and products availability.
Shelf life: 24 /36 months
Instructions for use
Transport Storage and operating Temperature:
Storage conditions: The test kit should be stored at 2-8 °C. (of as per stability studies guidelines)
Do not freeze
Transportation conditions
Operating Temperature: use at 15-25 within 10 minutes (of as IFU guidelines)
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/ 745 US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Note: CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking
Classification: Classified under EU MDR 2017/745 as Class I device
Environmental requirements: Rohs compliance
| Pack Size | Avg. Price |
|---|---|
| Pack of 25 | $25.00 |
