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Trichinella spiralis IgG ELISA Test Kit

FDA UDI

Class I (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Trichinella spiralis IgG ELISA Test Kit FDA UDI
Generic Name
Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Trichinella spiralis IgG ELISA Test Kit FDA UDI
Model / Reference
GSD01-3002 FDA UDI
Description
Trichinella spiralis IgG ELISA Test Kit FDA UDI

Identifiers

Catalog Number
GSD01-3002 FDA UDI
Primary DI / UDI-DI
B350GSD0130020 FDA UDI
FDA Product Code
MDT FDA UDI
GMDN Term
Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3850 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trichinella spiralis IgG ELISA Test Kit by Gold Standard Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

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 353e7bff-7d11-4119-a805-71577cc45dac 35 fields · synced Jun 8, 2026