|
Device | ABBOTT REAL TIME HBV CALIBRATOR KIT |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P100017 |
Supplement Number | S008 |
Date Received | 10/21/2013 |
Decision Date | 11/19/2013 |
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 MANUFACTURING PROCESS CHANGES AND QC IN-PROCESS METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE. |