Identity
- Trade Name
- GSD Brucella IgG ELISA FDA UDI
- Generic Name
- Multiple Brucella species total antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Brucella IgG ELISA Test Kit FDA UDI
- Model / Reference
- GSD01-3007 FDA UDI
- Description
- Brucella IgG ELISA Test Kit FDA UDI
Identifiers
- Catalog Number
- GSD01-3007 FDA UDI
- Primary DI / UDI-DI
- B350GSD0130070 FDA UDI
- FDA Product Code
- GSM FDA UDI
- GMDN Term
- Multiple Brucella species total antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3085 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
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: Multiple Brucella species total antibody IVD, kit, enzyme immunoassay (EIA)
GSD Brucella IgG ELISA by Gold Standard Diagnostics, LLC — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 93ac92b5-270c-41a0-9bbb-5e62a96667fa 35 fields · synced Jun 8, 2026