|
Device | ABBOTT REALTIME HBV ASSAY |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P080026 |
Supplement Number | S002 |
Date Received | 07/01/2011 |
Decision Date | 11/30/2011 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A RAW MATERIAL CHANGE FOR TWO OF THE MICROVIALS USED TO MANUFACTURE THE REAGENT COMPONENTS IN THE ABBOTT REALTIME HBV AMPLIFICATION KIT WITHIN THE ABBOTT REALTIME HBV ASSAY. |