VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI
FDA premarket approval P000044/S020 · decided 2009-10-23
Approval details
- PMA number
- P000044
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2009-02-02
- Decision date
- 2009-10-23
- Days to decision
- 263 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 5600 INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE VITROS HBSAG ASSAY AND THE VITROS HBSAG CONFIRMATORY KIT. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR AND VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KIT AND IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT P
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