VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
FDA premarket approval P090028 · decided 2011-05-11
Approval details
- PMA number
- P090028
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2009-12-16
- Decision date
- 2011-05-11
- Days to decision
- 511 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK, CALIBRATOR AND CONTROLS. THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM. TEST RESULTS, IN CONJUNCTION WITH OTH
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