Aptima HBV Quant Assay
FDA premarket approval P170025 · decided 2018-01-23
Approval details
- PMA number
- P170025
- Trade name
- Aptima HBV Quant Assay
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Hologic, Inc.
- Date received
- 2017-07-31
- Decision date
- 2018-01-23
- Days to decision
- 176 days
- Decision code
- APRL
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the Aptima HBV Quant assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system.Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPTs). Serum may be prepared inserum tubes and serum separator tubes (SSTs). Specimens are tested using the fullyautomated Panther system for sample proc
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