Aptima HBV Quant Assay
FDA premarket approval P170025/S005 · decided 2018-10-31
Approval details
- PMA number
- P170025
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Aptima HBV Quant Assay
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Hologic, Inc.
- Date received
- 2018-10-03
- Decision date
- 2018-10-31
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Removal of raw material QC testing not relevant to the product.
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