PMA P160016S003
- Device
- VERSANT HCV Genotype 2.0 Assay (LiPA)
- Applicant
- Fujirebio Europe N.V.
- PMA number
- P160016
- Supplement
- S003
- Product code
- OBF
- Decision date
- 2019-04-05
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- Relocation of reagent manufacture from one building to another within the same establishment.
Current openFDA PMA Record#
- Device
- VERSANT HCV Genotype 2.0 Assay (LiPA)
- Applicant
- Fujirebio Europe N.V.
- PMA number
- P160016
- Supplement
- S003
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2019-04-05
- Decision code
- OK30
- Date received
- 2019-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of reagent manufacture from one building to another within the same establishment.