Identity
- Trade Name
- Borrelia B31 ViraChip IgM Deca 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-BBCMDK 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-BBCMDK FDA UDI
- Primary DI / UDI-DI
- EVIRBBCMDK1 FDA UDI
- 510(k) Number
- K163695 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Borrelia burgdorferi total antibody IVD, kit, immunoblot
A medical device for the detection of Borrelia burgdorferi total antibodies in clinical specimens, using an immunoblot method. The Borrelia B31 ViraChip IgM Deca Kit is a reagent collection and associated materials designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.
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
K163695 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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 d628452c-5691-4351-86ee-fc7d2c138fae 38 fields · synced Jul 25, 2026