PMA P160023S005
- Device
- Aptima HCV Quant Dx Assay
- Applicant
- Hologic, Inc.
- PMA number
- P160023
- Supplement
- S005
- Product code
- MZP
- Decision date
- 2018-08-07
- 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
- Increase the batch size and modify the manufacturing process of a critical kit subcomponent.
Current openFDA PMA Record#
- Device
- Aptima HCV Quant Dx Assay
- Applicant
- Hologic, Inc.
- PMA number
- P160023
- Supplement
- S005
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2018-08-07
- Decision code
- OK30
- Date received
- 2018-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase the batch size and modify the manufacturing process of a critical kit subcomponent.