Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) |
Generic Name | Assay, genotyping, hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | ABBOTT MOLECULAR 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P120012 |
Supplement Number | S012 |
Date Received | 03/28/2016 |
Decision Date | 04/12/2016 |
Reclassified Date
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12/22/2021 |
Product Code |
OBF |
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 Change to consolidate the current QC testing for the Amplification Reagent Kit from two stages into a single finished kit QC stage. |
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