| 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 | ORAQUICK HCV RAPID ANTIBODY TEST |
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| Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
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| Applicant | ORASURE TECHNOLOGIES INC.
220 East First Street
Bethlehem, PA 18015 |
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| PMA Number | P080027 |
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| Supplement Number | S001 |
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| Date Received | 08/03/2010 |
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| Decision Date | 02/18/2011 |
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Reclassified Date
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12/22/2021 |
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| Product Code |
MZO |
| Docket Number | 11M-0132 |
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| Notice Date | 03/09/2011 |
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| Advisory Committee |
Microbiology |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE ORAQUICK HCV RAPID ANTIBODY TEST IS A SINGLE-USE IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN FINGERSTICK WHOLE BLOOD SPECIMENS AND VENIPUNCTURE WHOLE BLOOD SPECIMENS (EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, AND SODIUM CITRATE) FROM INDIVIDUALS 15 YEARS OR OLDER. THE ORAQUICK HCV RAPID ANTIBODY TEST RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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