COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
FDA premarket approval P050028/S017 · decided 2011-07-07
Approval details
- PMA number
- P050028
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-03-08
- Decision date
- 2011-07-07
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR CHANGES TO IN-PROCESS TESTING PROCEDURES FOR THE ELUTION BUFFER AND MANGANESE REAGENT TO BE IMPLEMENTED AT THE MANUFACTURING SITE IN SOMERVILLE, NEW JERSEY.
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