Product Name: HIV Ag/Ab Combination
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 or plasma.
Name of Reagent:
Product Code
Specimen or Sample Type to Be Used: Serum or 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 or not in the package.
Name of Instruments or Component, if Applicable:
Product Code
Packaging and Labelling:
Test Pouch
Cartridge Guide
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:
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 or plasma.
Name of Reagent:
Product Code
Specimen or Sample Type to Be Used: Serum or 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 or not in the package.
Name of Instruments or Component, if Applicable:
Product Code
Packaging and Labelling:
Test Pouch
Cartridge Guide
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 25 | $25.00 |
