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 HBV |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P080026 |
Supplement Number | S016 |
Date Received | 07/29/2015 |
Decision Date | 10/09/2015 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID. |
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