VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS
FDA premarket approval P000014/S009 · decided 2004-09-27
Approval details
- PMA number
- P000014
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2004-09-15
- Decision date
- 2004-09-27
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR A CHANGE FROM THE QUALITATIVE DETECTION OF TOTAL ANTI-HBS IN HUMAN SERUM TO A QUANTITATIVE DETECTION OF TOTAL ANTI-HBS IN HUMAN SERUM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS. THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK IS INDICATED FOR: "THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS
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