DIASORIN HBSAG CONFIRMATORY TEST
FDA premarket approval P990038/S004 · decided 2003-03-14
Approval details
- PMA number
- P990038
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIASORIN HBSAG CONFIRMATORY TEST
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2002-10-29
- Decision date
- 2003-03-14
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR USE OF A DIASORIN HBSAG CONFIRMATORY REAGENT TO CONFIRM ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES, AND USE OF A DIASORIN CONFIRMATORY REAGENT SPECIFICALLY IN PRENATAL SCREENING TO CONFIRM ALL ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES IN THE ABSENCE OF OTHER HBV MARKER TESTING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIASORIN HBSAG CONFIRMATORY TEST AND IS INDICATED FOR AN IN VITRO NEUTRALIZATION ASSAY FOR QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS
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