|
Device | VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | GEN-PROBE 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 |
PMA Number | P020011 |
Supplement Number | S004 |
Date Received | 08/23/2010 |
Decision Date | 09/17/2010 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |