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Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit FDA UDI
- Generic Name
- Borrelia burgdorferi total antibody IVD, kit, immunoblot FDA UDI
- Device Name
- Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit FDA UDI
- Model / Reference
- GSD01-1018 FDA UDI
- Description
- Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit FDA UDI
Identifiers
- Catalog Number
- GSD01-1018 FDA UDI
- Primary DI / UDI-DI
- B350GSD0110180 FDA UDI
- 510(k) Number
- K113847 FDA UDI
- FDA Product Code
- LSR FDA UDI
- GMDN Term
- Borrelia burgdorferi total antibody IVD, kit, immunoblot FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3830 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
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
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 0ae3d8bc-f8f5-42b9-b674-dc5859e4b2dd 36 fields · synced Jun 8, 2026