PMA P120012S001
- Device
- ABBOTT REAL TIME HCV GENOTYPE 11
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S001
- Product code
- OBF
- Decision date
- 2013-08-01
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- CHANGE TO THE SAMPLING PLAN FOR THE REAGENT VIAL FILLING PROCEDURE.
Current openFDA PMA Record#
- Device
- ABBOTT REAL TIME HCV GENOTYPE 11
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S001
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2013-08-01
- Decision code
- OK30
- Date received
- 2013-07-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SAMPLING PLAN FOR THE REAGENT VIAL FILLING PROCEDURE.