Identity
- Trade Name
- α2-Makroglobulin ELISA FDA UDI
- Generic Name
- Alpha-2-macroglobulin IVD, reagent FDA UDI
- Model / Reference
- K 6610A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050598000872 FDA UDI
- FDA Product Code
- DEB FDA UDI
- GMDN Term
- Alpha-2-macroglobulin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5620 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alpha-2-macroglobulin IVD, reagent
α2-Makroglobulin ELISA by Immundiagnostik, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-2-macroglobulin IVD, reagent.
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- Alpha 2 Macroglobulin RID plate package — KENT LABORATORIES, INC. · Class I
- Alpha 2 Macroglobulin RID kit — KENT LABORATORIES, INC. · Class I
- Antiserum to Human Alpha 2 Macroglobulin — KENT LABORATORIES, INC. · Class II
- α2-Makroglobulin ELISA — IMMUNDIAGNOSTIK, INC. · Class II
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
- Immundiagnostik, Inc.
Sources (1)
- FDA UDI 7bcfd6f7-25a0-4652-8169-ad48a06ba593 33 fields · synced May 30, 2026