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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

FDA premarket approval P030024/S001 · decided 2004-04-02

Approval details

PMA number
P030024
Supplement
S001
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Applicant
Ortho-Clinical Diagnostics
Date received
2004-03-17
Decision date
2004-04-02
Days to decision
16 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 REDUCTION OF PRODUCTION WASTE FOR THE MANUFACTURE OF THE COATED MICROWELLS.

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