ABBOTT REALTIME HVB ASSAY
FDA premarket approval P080026/S013 · decided 2014-12-10
Approval details
- PMA number
- P080026
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT REALTIME HVB ASSAY
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2014-11-10
- Decision date
- 2014-12-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES AT THE CONTRACT TESTING LABORATORY.
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