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Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit

FDA UDI

Class N (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit FDA UDI
Generic Name
SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). FDA UDI
Model / Reference
GSD01-1029 FDA UDI
Description
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). FDA UDI

Identifiers

Catalog Number
GSD01-1029 FDA UDI
Primary DI / UDI-DI
B350GSD0110290 FDA UDI
FDA Product Code
QJR FDA UDI
GMDN Term
SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
N 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 SARS-CoV-2 IgA ELISA Test Kit by Gold Standard Diagnostics, LLC — Class N — 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 7e09f02b-42a7-49f4-85f2-980cb45e1464 36 fields · synced Jun 8, 2026