Identity
- Trade Name
- Alinity m FDA UDI
- Generic Name
- Molecular grade alcohol IVD FDA UDI
- Device Name
- Alinity m Ethanol Solution FDA UDI
- Model / Reference
- 09N20-002 FDA UDI
- Description
- Alinity m Ethanol Solution FDA UDI
Identifiers
- Catalog Number
- 09N20-002 FDA UDI
- Primary DI / UDI-DI
- 00884999047693 FDA UDI
- FDA Product Code
- MKZ FDA UDIQEP FDA UDIOUY FDA UDIOOI FDA UDILSL FDA UDI
- GMDN Term
- Molecular grade alcohol IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3120 FDA UDI866.3393 FDA UDI866.3860 FDA UDI862.2570 FDA UDI866.3390 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
No
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: Molecular grade alcohol IVD
Alinity m by Abbott Molecular — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI d737f5cb-d3cc-4fe0-8541-0b5ace7710ee 36 fields · synced Jun 8, 2026