← Back to catalogue
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit FDA UDI
- Generic Name
- Borrelia burgdorferi total antibody IVD, kit, immunoblot FDA UDI
- Device Name
- Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack FDA UDI
- Model / Reference
- GSD10-1023 FDA UDI
- Description
- Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack FDA UDI
Identifiers
- Catalog Number
- GSD10-1023 FDA UDI
- Primary DI / UDI-DI
- B350GSD1010230 FDA UDI
- 510(k) Number
- K113846 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
- 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: Borrelia burgdorferi total antibody IVD, kit, immunoblot
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Borrelia burgdorferi total antibody IVD, kit, immunoblot.
- Borrelia B31 IgM ViraStripe® Test Kit — Viramed Biotech AG · Class II
- Borrelia B31 ViraChip IgG Deca Kit — Viramed Biotech AG · Class II
- Borrelia All-In-One ViraChip Test Kit — Viramed Biotech AG · Class II
- Borrelia B31 ViraChip IgM Deca Kit — Viramed Biotech AG · Class II
- Borrelia B31 IgM ViraStripe® Deca Kit — Viramed Biotech AG · Class II
- Borrelia B31 ViraChip® IgM Test Kit — Viramed Biotech AG · Class II
- Borrelia B31 IgG ViraStripe® Test Kit — Viramed Biotech AG · Class II
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI cb86efb8-213f-49fe-a6cf-cc39f0a80216 36 fields · synced Jun 8, 2026