Identity
- Trade Name
- BGM GALECTIN-3 FDA UDI
- Generic Name
- Galectin-3 IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Galectin-3 In Vitro Diagnostic Assay FDA UDI
- Model / Reference
- 001 FDA UDI
- Description
- Galectin-3 In Vitro Diagnostic Assay FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867444000207 FDA UDI
- 510(k) Number
- K093758 FDA UDI
- FDA Product Code
- OSX FDA UDI
- GMDN Term
- Galectin-3 IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1117 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: Galectin-3 IVD, kit, enzyme immunoassay (EIA)
Bgm Galectin-3 by Corgenix Medical Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Corgenix Medical Corporation
Sources (1)
- FDA UDI f2b74c1d-6722-4ed3-bbff-3468bcaaff30 35 fields · synced May 30, 2026