← Back to catalogue

Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit

FDA UDI

Class II (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit FDA UDI
Generic Name
Borrelia burgdorferi antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit FDA UDI
Model / Reference
GSD01-1027 FDA UDI
Description
Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit FDA UDI

Identifiers

Catalog Number
GSD01-1027 FDA UDI
Primary DI / UDI-DI
B350GSD0110270 FDA UDI
510(k) Number
K203289 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
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 antigen IVD, kit, enzyme immunoassay (EIA)

Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Borrelia burgdorferi antigen IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gold Standard Diagnostics, LLC

Sources (1)

  • FDA UDI 9ad8ed12-66e8-4ac5-8fbb-31b383a461a4 36 fields · synced Jun 8, 2026