Identity
- Trade Name
- Borrelia B31 IgM ViraStripe® Test Kit FDA UDI
- Generic Name
- Borrelia burgdorferi total antibody IVD, kit, immunoblot FDA UDI
- Device Name
- Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum. FDA UDI
- Model / Reference
- V-BBSMUS FDA UDI
- Description
- Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum. FDA UDI
Identifiers
- Catalog Number
- V-BBSMUS FDA UDI
- Primary DI / UDI-DI
- EVIRBBSMUS1 FDA UDI
- 510(k) Number
- K082329 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
No
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: Borrelia burgdorferi total antibody IVD, kit, immunoblot
Borrelia B31 IgM ViraStripe® Test Kit by Viramed Biotech AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Borrelia burgdorferi total antibody IVD, kit, immunoblot.
- Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit — Gold Standard Diagnostics, LLC · Class II
- Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class I
- Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit — Gold Standard Diagnostics, LLC · Class II
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
- Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit — Gold Standard Diagnostics, LLC · Class II
- Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit — Gold Standard Diagnostics, LLC · Class II
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
- Viramed Biotech AG
Sources (1)
- FDA UDI 71948bfa-ea45-44e6-95e0-718f6a6b3882 38 fields · synced May 30, 2026