PMA P120012S004
- Device
- ABBOTT REAL TIME HCV GENOTYPE II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S004
- Product code
- OBF
- Decision date
- 2014-09-25
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- MANUFACTURING PROCESS CHANGES AND IN-PROCESS QUALITY CONTROL METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE.
Current openFDA PMA Record#
- Device
- ABBOTT REAL TIME HCV GENOTYPE II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S004
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2014-09-25
- Decision code
- OK30
- Date received
- 2014-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING PROCESS CHANGES AND IN-PROCESS QUALITY CONTROL METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE.