Infectious disease
HBsAg Rapid TestIn development
Lateral flow rapid test for the qualitative detection of hepatitis b surface antigen in serum, plasma, whole blood. In development — not released for sale.
- Analytes
- Hepatitis B surface antigen
- Sample types
- Serum, plasma, whole blood
- Method
- Lateral flow immunoassay, colloidal gold conjugate
- Format
- Cassette with buffer and disposable pipette
Infectious disease
HBsAg Rapid Test
Performance
- Sensitivity
- To be established
- Specificity
- To be established
- Read time
- To be established
Handling
- Shelf life
- To be established
- Storage temperature
- To be established
Intended use
For the qualitative detection of Hepatitis B surface antigen as an aid in diagnosis. In development — not released for sale.
Regulatory
Claims on file
- CDSCO licence no.
- Not published
- ICMR registration
- Not published
- ISO 13485
- Not published
- ISO 9001
- Not published
- CE mark
- Not published
- GMP
- Not published
No certificate number published for this product
A certification appears here only once it carries a number and a scanned certificate. Nothing is claimed that cannot be checked.
Certificate numbers pending — see DECISIONS.md D3.