ORAQUICK HCV RAPID ANTIBODY TEST
FDA premarket approval P080027 · decided 2010-06-25
Approval details
- PMA number
- P080027
- Trade name
- ORAQUICK HCV RAPID ANTIBODY TEST
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- OraSure Technologies, Inc.
- Date received
- 2008-10-24
- Decision date
- 2010-06-25
- Days to decision
- 609 days
- Decision code
- APRL
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Bethlehem, PA
- 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 ASSOCIATE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OraQuick Ebola Rapid Antigen Test (DEN190025) | OraSure Technologies, Inc. | 2019-10-10 |
| COMPOUND W FREEZE OFF WART REMOVAL SYSTEM (K060859) | OraSure Technologies, Inc. | 2006-07-18 |
| HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME (K023487) | OraSure Technologies, Inc. | 2003-03-20 |
| OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (K013882) | OraSure Technologies, Inc. | 2002-04-17 |
| UPLINK TEST SYSTEM (K020371) | OraSure Technologies, Inc. | 2002-04-03 |
| INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (K011057) | OraSure Technologies, Inc. | 2001-06-06 |
| STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (K002375) | OraSure Technologies, Inc. | 2001-01-26 |
| STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (K001976) | OraSure Technologies, Inc. | 2000-12-06 |