COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0
FDA premarket approval P050028/S012 · decided 2010-12-07
Approval details
- PMA number
- P050028
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2010-11-08
- Decision date
- 2010-12-07
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- CLEAN IN PLACE CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE TWO LARGE SCALE BULK FORMULATION (LSBF) 10,000 L TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINE WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER FACILITY IN BRANCHBURG, NEW JERSEY.
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