PMA P120012S006
- Device
- REALTIME HCV GENOTYPE II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S006
- Product code
- OBF
- Decision date
- 2014-12-10
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES AT THE CONTRACT TESTING LABORATORY.
Current openFDA PMA Record#
- Device
- REALTIME HCV GENOTYPE II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S006
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2014-12-10
- Decision code
- OK30
- Date received
- 2014-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES AT THE CONTRACT TESTING LABORATORY.