ABBOTT REALTIME HBV ASSAY
FDA premarket approval P080026 · decided 2010-08-13
Approval details
- PMA number
- P080026
- Trade name
- ABBOTT REALTIME HBV ASSAY
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2008-10-16
- Decision date
- 2010-08-13
- Days to decision
- 666 days
- Decision code
- APRL
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR THE ABBOTTREALTIME HBV. THE DEVICE IS INDICATED FOR:ABBOTT REALTIME HBV ASSAY:ABBOTT REALTIME HBV ASSAY IS AN IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY FOR USE WITH THE ABBOTT M2000 SYSTEMDNA REAGENTS AND WITH THE ABBOTT M200SP AND M2OOORT INSTRUMENTSFOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA (EDTA) FROM CHRONICALLY HBV-INFECTED INDIVIDUALS. THE ASSAY IS INTENDED FOR USE AS AN AID IN THEMANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOI
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
| Alinity m EBV (09N43-095) (K243489) | Abbott Molecular, Inc. | 2025-07-28 |
| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| Alinity m BKV (K241921) | Abbott Molecular, Inc. | 2025-03-24 |
| Alinity m Resp-4-Plex (K241573) | Abbott Molecular, Inc. | 2025-02-14 |
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Alinity m STI Assay (K222379) | Abbott Molecular, Inc. | 2023-03-03 |
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) | Abbott Molecular, Inc. | 2022-07-15 |