Identity
- Trade Name
- GBM IgG Test System FDA UDI
- Generic Name
- Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- GBM396 FDA UDI
Identifiers
- Catalog Number
- GBM396 FDA UDI
- Primary DI / UDI-DI
- 00813545029029 FDA UDI
- FDA Product Code
- DBL FDA UDI
- GMDN Term
- Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 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: Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA)
GBM IgG Test System by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA).
- QUANTA Lite® GBM ELISA — INOVA DIAGNOSTICS, INC. · Class II
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- QUANTA Lite® GBM ELISA Bulk Pack — INOVA DIAGNOSTICS, 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
- Scimedx Corp.
Sources (1)
- FDA UDI 31dfa621-e463-4934-b8cb-1b0ac3a58cec 34 fields · synced May 31, 2026