COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
FDA premarket approval P050028/S011 · decided 2011-06-24
Approval details
- PMA number
- P050028
- Supplement
- S011
- 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
- 2010-09-22
- Decision date
- 2011-06-24
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR AN ADDITION OF A SECOND SINTERING OVEN FOR THE MANUFACTURE OF THE BULK MAGNETIC GLASS PARTICLE (MGP) RAW MATERIAL USED IN THE PRODUCTION OF THE MPG REAGENT.
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510(k) clearances by this applicant
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