Product Name: Anti-HIV 1+2 ELISA
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 or Sample Type to Be Used: Serum or 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, Instructions for Use (IFU).
Note: Accessories requirements must be specified by suppliers whether they are included or not in the package.
Name of Instruments or Component, if Applicable:
Product Code
Packaging and Labelling:
Pack Size: 30, 50, or 100 test pouch
Cartridge Guide
Note: Pack sizes are not limited to those indicated above. Larger or smaller pack sizes may be considered based on UNFPA needs and product 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 (or as per stability studies guidelines).
Do not freeze.
Transportation Conditions:
Operating Temperature: Use at 15-25°C within 10 minutes (or as per IFU guidelines).
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/745 or 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 the CE marking.
Classification:
Classified under EU MDR 2017/745 as a Class I device
Environmental Requirements:
RoHS compliance.
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 or Sample Type to Be Used: Serum or 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, Instructions for Use (IFU).
Note: Accessories requirements must be specified by suppliers whether they are included or not in the package.
Name of Instruments or Component, if Applicable:
Product Code
Packaging and Labelling:
Pack Size: 30, 50, or 100 test pouch
Cartridge Guide
Note: Pack sizes are not limited to those indicated above. Larger or smaller pack sizes may be considered based on UNFPA needs and product 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 (or as per stability studies guidelines).
Do not freeze.
Transportation Conditions:
Operating Temperature: Use at 15-25°C within 10 minutes (or as per IFU guidelines).
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/745 or 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 the CE marking.
Classification:
Classified under EU MDR 2017/745 as a Class I device
Environmental Requirements:
RoHS compliance.
| Pack Size | Avg. Price |
|---|---|
| Pack of 96 | $37.44 |
