PMA P120012S003
- Device
- ABBOTT REALTIME HCV GENOTYPE II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S003
- Product code
- OBF
- Decision date
- 2013-08-20
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- CHANGE TO THE MANUFACTURING PROCESS FOR OLIGONUCLEOTIDES AND THE ADDITION OF TWO NEW SUPPLIERS FOR A RAW MATERIAL.
Current openFDA PMA Record#
- Device
- ABBOTT REALTIME HCV GENOTYPE II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S003
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2013-08-20
- Decision code
- OK30
- Date received
- 2013-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MANUFACTURING PROCESS FOR OLIGONUCLEOTIDES AND THE ADDITION OF TWO NEW SUPPLIERS FOR A RAW MATERIAL.