Identity
- Trade Name
- α1-Microglobulin ELISA FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Assay is intended for the quantitative determination of a1-Microglobulin in serum, plasma and urine. FDA UDI
- Model / Reference
- EIA-5100 FDA UDI
- Description
- The Assay is intended for the quantitative determination of a1-Microglobulin in serum, plasma and urine. FDA UDI
Identifiers
- Catalog Number
- EIA-5100 FDA UDI
- Primary DI / UDI-DI
- 04048474051001 FDA UDI
- FDA Product Code
- MGA FDA UDI
- GMDN Term
- Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5400 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
α1-Microglobulin ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — 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
Sources (1)
- FDA UDI a5f2d307-7e5d-4b46-9cbc-b17364cacda5 37 fields · synced Jun 8, 2026