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 | VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P010021 |
Supplement Number | S021 |
Date Received | 10/05/2011 |
Decision Date | 11/10/2011 |
Reclassified Date
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12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS. |
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