ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
FDA premarket approval P040018 · decided 2004-12-22
Approval details
- PMA number
- P040018
- Trade name
- ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Bayer Healthcare, LLC
- Date received
- 2004-04-01
- Decision date
- 2004-12-22
- Days to decision
- 265 days
- Decision code
- APRL
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR THE ADVIA CENTAUR HAV IGM. HAV IGM READYPACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HAV IGM ASSAY AND IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IGM RESPONSE TO THE HEPATITIS A VIRUS (HAV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT INFECTION (USUALLY 6 MONTHS OR LESS) WITH HEPATITIS A VIRUS
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