Identity
- Trade Name
- Alinity m FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) nucleic acid IVD, calibrator FDA UDI
- Device Name
- Alinity m EBV CTRL Kit FDA UDI
- Model / Reference
- 09N43-075 FDA UDI
- Description
- Alinity m EBV CTRL Kit FDA UDI
Identifiers
- Catalog Number
- 09N43-075 FDA UDI
- Primary DI / UDI-DI
- 00884999049482 FDA UDI
- 510(k) Number
- K212778 FDA UDI
- FDA Product Code
- QLX FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) nucleic acid IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3183 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Epstein-Barr virus (EBV) nucleic acid IVD, calibrator
Alinity m by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus (EBV) nucleic acid IVD, calibrator.
- Exact Diagnostics — Exact Diagnostics · Class II
Cleared under the same submission
K212778 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI 280f06ff-5892-4711-a858-2f06ce0dd26f 37 fields · synced Jun 8, 2026