510(k) K212778
- Device
- 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)
- Applicant
- Abbott Molecular, Inc.
- 510(k) number
- K212778
- Product code
- QLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-15
- Date received
- 2021-09-01
- Regulation
- 866.3183
- Classification name
- Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gina Sammarco
- Address
- 1300 E Touhy Ave. Des Plaines IL US 60018 60018
FDA Registration Numbers#
- 3025663244
- 2023365
- 9610126
- 3005248192
- 3004141078
- 3003795116
- 2243471
Source Documents#
Other 510(k) Records For Product Code QLX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243489 | Alinity m EBV (09N43-095) | Abbott Molecular, Inc. | 2025-07-28 |
| K203220 | cobas BKV | Roche Molecular Systems, Inc. | 2021-01-29 |
| DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020-07-30 |
Legacy Summary#
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FDA Review#
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