ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
FDA premarket approval P140021 · decided 2015-06-11
Approval details
- PMA number
- P140021
- Trade name
- ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2014-10-01
- Decision date
- 2015-06-11
- Days to decision
- 253 days
- Decision code
- APRL
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR THE ELECSYS ANTI-HCV II IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HCV. THIS DEVICE IS INDICATED FOR: ELECSYS ANTI-HCV II IMMUNOASSAYIMMUNOASSAY FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN ADULT AND PEDIATRIC (AGES 18 MONTHS THROUGH 21 YEARS) SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, AND SODIUM CITRATE). ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366) | Roche Diagnostics Operations, Inc. | 2013-10-11 |
| ACCU-CHEK AVIVA PLUS TEST STRIP (K131029) | Roche Diagnostics Operations, Inc. | 2013-08-09 |