VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
FDA premarket approval P100001 · decided 2011-07-20
Approval details
- PMA number
- P100001
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Ortho-Clinical Diagnostics
- Date received
- 2010-01-29
- Decision date
- 2011-07-20
- Days to decision
- 537 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, CALIBRATOR AND CONTROLS. THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF CHRONIC HEPATITIS AND THOSE WHO HAVE RECOVERED FROM HBV INFECTION, USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS. FURTHER ASSESSME
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