VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
FDA premarket approval P000014/S019 · decided 2010-01-11
Approval details
- PMA number
- P000014
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2009-09-04
- Decision date
- 2010-01-11
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE VITROSIMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDERTHE TRADE NAMES VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATOR, AND IS INDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK:FOR THE QUANTITATIVE IN VITRO DETERM
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