PMA P160016S006
- Device
- VERSANT HCV Genotype 2.0 Assay (LiPA)
- Applicant
- Fujirebio Europe N.V.
- PMA number
- P160016
- Supplement
- S006
- Product code
- OBF
- Decision date
- 2020-08-27
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- Manufacturing process change to replace with new RNA QC samples.
Current openFDA PMA Record#
- Device
- VERSANT HCV Genotype 2.0 Assay (LiPA)
- Applicant
- Fujirebio Europe N.V.
- PMA number
- P160016
- Supplement
- S006
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2020-08-27
- Decision code
- OK30
- Date received
- 2020-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change to replace with new RNA QC samples.