PMA P020011S004
- Device
- VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S004
- Product code
- MZP
- Decision date
- 2010-09-17
- 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
- MODIFICATION TO THE PURIFICATION AND DESALTING PROCESSES FOR TWO CLASSES OF OLIGONUCLEOTIDES (RXL INTERMEDIATES AND PPOS), WHICH ARE COMPONENTS OF SOME REAGENTS OF THE DEVICE.
Current openFDA PMA Record#
- Device
- VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S004
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2010-09-17
- Decision code
- OK30
- Date received
- 2010-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO THE PURIFICATION AND DESALTING PROCESSES FOR TWO CLASSES OF OLIGONUCLEOTIDES (RXL INTERMEDIATES AND PPOS), WHICH ARE COMPONENTS OF SOME REAGENTS OF THE DEVICE.