PMA P020011S001
- Device
- VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S001
- Product code
- MZP
- Decision date
- 2009-05-22
- Classification
- Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- CHANGE OF THE ACTIVATOR USED IN THE SYNTHESIS OF DNA OLIGONUCLEOTIDES FROM 1-H TETRAZOLE TO 5-ETHYLTHIO 1-H TETRAZOLE (ETT) AND THE ADDITION OF SIGMA-ALDRICH (SAFC) AS A SECONDARY SUPPLIER OF THE NEW ACTIVATOR (ETT).
Current openFDA PMA Record#
- Device
- VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S001
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2009-05-22
- Decision code
- OK30
- Date received
- 2009-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF THE ACTIVATOR USED IN THE SYNTHESIS OF DNA OLIGONUCLEOTIDES FROM 1-H TETRAZOLE TO 5-ETHYLTHIO 1-H TETRAZOLE (ETT) AND THE ADDITION OF SIGMA-ALDRICH (SAFC) AS A SECONDARY SUPPLIER OF THE NEW ACTIVATOR (ETT).