COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0
FDA premarket approval P050028/S023 · decided 2012-09-18
Approval details
- PMA number
- P050028
- Supplement
- S023
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-12-12
- Decision date
- 2012-09-18
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE MANUFACTURING CHANGES TO THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR THE VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.
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510(k) clearances by this applicant
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