Alinity m HBV
FDA premarket approval P200013 · decided 2020-08-29
Approval details
- PMA number
- P200013
- Trade name
- Alinity m HBV
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2020-03-02
- Decision date
- 2020-08-29
- Days to decision
- 180 days
- Decision code
- APRL
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Approval for the Alinity m HBV. The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) with fluorescent labeled probes assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma and serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing res
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |