ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
FDA premarket approval P130015 · decided 2014-03-14
Approval details
- PMA number
- P130015
- Trade name
- ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2013-05-30
- Decision date
- 2014-03-14
- Days to decision
- 288 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR THE ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG. THIS DEVICE IS INDICATED FOR:ELECSYS HBEAG IMMUNOASSAYTHE ELECSYS HBEAG IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM OR PLASMA (K2-EDTA, LITHIUM OR SODIUM HEPARIN, AND SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION. THE ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORM
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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 |