OraQuick HCV Rapid Antibody Test
FDA premarket approval P080027/S035 · decided 2019-09-11
Approval details
- PMA number
- P080027
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OraQuick HCV Rapid Antibody Test
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- OraSure Technologies, Inc.
- Date received
- 2019-08-16
- Decision date
- 2019-09-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Bethlehem, PA
- Statement
- Modification of an existing automated assembly system for manufacturing.
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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 |