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Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit

FDA UDI

Class II (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit FDA UDI
Model / Reference
720-300 FDA UDI
Description
Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit FDA UDI

Identifiers

Catalog Number
720-300 FDA UDI
Primary DI / UDI-DI
B3507203000 FDA UDI
510(k) Number
K981498 FDA UDI
FDA Product Code
LGD FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3780 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

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: Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K981498 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 83e3bd9d-2140-46a6-b277-4e1881545e54 36 fields · synced Jun 8, 2026