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Toxo IgG IFA 120 Test

FDA UDI

Class II (US FDA UDI)

by Hemagen Diagnostics, Inc.

Identity

Trade Name
Toxo IgG IFA 120 Test FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
For the detection and titration of Toxoplasma gondii IgG antibodies FDA UDI
Model / Reference
902010 FDA UDI
Description
For the detection and titration of Toxoplasma gondii IgG antibodies FDA UDI

Identifiers

Primary DI / UDI-DI
G5229020101 FDA UDI
FDA Product Code
GLZ FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay 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

Yes

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: Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Toxo IgG IFA 120 Test by Hemagen Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hemagen Diagnostics, Inc.

Sources (1)

  • FDA UDI 9cde7ace-390c-4ea8-8424-ef705cf13281 35 fields · synced Jun 6, 2026