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Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit

FDA UDI

Class II (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit FDA UDI
Generic Name
Borrelia burgdorferi antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit FDA UDI
Model / Reference
GSD10-1024 FDA UDI
Description
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit FDA UDI

Identifiers

Catalog Number
GSD10-1024 FDA UDI
Primary DI / UDI-DI
B350GSD0110240 FDA UDI
FDA Product Code
LSR FDA UDI
GMDN Term
Borrelia burgdorferi antigen IVD, kit, enzyme immunoassay (EIA) 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 burgodorferi IgG/IgM ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID

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 693544c1-992a-47ca-a722-83c34c65f69e 36 fields · synced Jun 8, 2026