VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
FDA premarket approval P000014/S007 · decided 2004-05-14
Approval details
- PMA number
- P000014
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2004-05-05
- Decision date
- 2004-05-14
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- REPLACEMENT OF KEY EQUIPMENT USED IN PERFORMING THE COATED WELL TEST PROCEDURE AND THE ACCEPTANCE CRITERIA ASSOCIATED WITH ITS USE. IN ADDITION, THE COATED WELL SAMPLING PLAN, RANDOMIZATION METHODS FOR SAMPLING, AND TEST ERROR CORRECTION METHODS HAVE BEEN IMPROVED TO FURTHER ENSURE BATCH QUALITY AND REDUCE PRODUCTION WASTE. THE COATED WELL TEST PROCEDURE IS USED TO VERIFY AN ACCEPTABLE LEVEL OF WELL-TO-WELL PRECISION AND OUTLIER-LEVEL INCIDENCE IN THE COATED WELLS MANUFACTURED FOR THE VITROS ANT
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