PMA P160023S001
- Device
- Aptima HCV Quant Dx Assay
- Applicant
- Hologic, Inc.
- PMA number
- P160023
- Supplement
- S001
- Product code
- MZP
- Decision date
- 2018-02-23
- Classification
- Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- Approval for the use of the Aptima HCV Quant Dx Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.
Current openFDA PMA Record#
- Device
- Aptima HCV Quant Dx Assay
- Applicant
- Hologic, Inc.
- PMA number
- P160023
- Supplement
- S001
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2018-02-23
- Decision code
- APPR
- Date received
- 2017-08-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of the Aptima HCV Quant Dx Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.