Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- Alinity s System FDA UDI
- Model / Reference
- 06P1601 FDA UDI
- Description
- Alinity s System FDA UDI
Identifiers
- Catalog Number
- 06P1601 FDA UDI
- Primary DI / UDI-DI
- 00380740138479 FDA UDI
- FDA Product Code
- MZA FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chemiluminescent immunoassay analyser IVD
Alinity by Abbott Laboratories, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bolt (CLIA) — Gold Standard Diagnostics, LLC · Class I
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 N | Pending data |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI 8e753c0f-f42b-4fc3-a1f3-d4289124c94f 36 fields · synced May 30, 2026