PMA P120012S005
- Device
- ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S005
- Product code
- OBF
- Decision date
- 2014-11-20
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- CHANGE TO ADD A SINGLE, AUTOMATED BOTTLING LINE FOR COMPONENT FILLING AND CAPPING.
Current openFDA PMA Record#
- Device
- ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S005
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2014-11-20
- Decision code
- OK30
- Date received
- 2014-10-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO ADD A SINGLE, AUTOMATED BOTTLING LINE FOR COMPONENT FILLING AND CAPPING.