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Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk

FDA UDI

Class II (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk 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 - Bulk Pack FDA UDI
Model / Reference
GSD04-1023 FDA UDI
Description
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk Pack FDA UDI

Identifiers

Catalog Number
GSD04-1023 FDA UDI
Primary DI / UDI-DI
B350GSD0410230 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
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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K113846 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gold Standard Diagnostics, LLC

Sources (1)

  • FDA UDI fe2bed3c-02b8-444e-94eb-6d1bc12ad85e 37 fields · synced Jun 8, 2026