IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected supplier.
Product name:
Anti-HIV 1+2 ELISA
Product code
Type of Immunoassay/ Analyte:
A two-step incubation antigen “sandwich” enzyme immunoassay, which uses polystyrene microwell strips pre-coated with recombinant HIV antigens expressed in E.coli (recombinant HIV-1gp41, gp120, and recombinant HIV-2 gp36).
Name of reagent
Product code
Specimen of sample type to be used: Serum of plasma
Accessories:
Microwell Plate, Negative Control, Positive Control-1, Positive Control-2, Hrp-Conjugate, Wash Buffer, Chromogen Solution A, Chromogen Solution B, Stop Solution, Plastic Sealable Bag, Cardboard Plate Cover, IFU.
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
These technical specifications are generic and may vary depending on the selected supplier.
Product name:
Anti-HIV 1+2 ELISA
Product code
Type of Immunoassay/ Analyte:
A two-step incubation antigen “sandwich” enzyme immunoassay, which uses polystyrene microwell strips pre-coated with recombinant HIV antigens expressed in E.coli (recombinant HIV-1gp41, gp120, and recombinant HIV-2 gp36).
Name of reagent
Product code
Specimen of sample type to be used: Serum of plasma
Accessories:
Microwell Plate, Negative Control, Positive Control-1, Positive Control-2, Hrp-Conjugate, Wash Buffer, Chromogen Solution A, Chromogen Solution B, Stop Solution, Plastic Sealable Bag, Cardboard Plate Cover, IFU.
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 96 | $37.44 |
