| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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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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| Date Received | 10/24/2008 |
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| Decision Date | 06/25/2010 |
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Reclassified Date
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12/22/2021 |
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| Product Code |
MZO |
| Docket Number | 10M-0402 |
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| Notice Date | 07/30/2010 |
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| Advisory Committee |
Microbiology |
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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 RAPID HCV ANTIBODY TEST. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN 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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| Supplements: |
S001 S003 S005 S006 S007 S008 S009 S010 S011 S012 S013
S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 S025 S026
S027 S028 S029 S030 S031 S032 S033 S034 S035 S037 S038 S039
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