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Pointe Scientific, Inc. Toxoplasma IgM

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific, Inc. Toxoplasma IgM FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quantitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. Patient testing with anti-Toxoplasma gondii IgM antibody assay, must be accompanied by an anti-Toxoplasma gondii IgG antibody assay. The assay’s performance characteristics have not been established for neonatal toxoplasmosis diagnosis. This assay has not been cleared / approved by the FDA for blood / plasma donor screening. 96 tests. FDA UDI
Model / Reference
T8002-96 FDA UDI
Description
Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quantitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. Patient testing with anti-Toxoplasma gondii IgM antibody assay, must be accompanied by an anti-Toxoplasma gondii IgG antibody assay. The assay’s performance characteristics have not been established for neonatal toxoplasmosis diagnosis. This assay has not been cleared / approved by the FDA for blood / plasma donor screening. 96 tests. FDA UDI

Identifiers

Catalog Number
T8002-96 FDA UDI
Primary DI / UDI-DI
00811727015167 FDA UDI
510(k) Number
K971672 FDA UDI
FDA Product Code
LGD FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin M (IgM) 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

No

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: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Pointe Scientific, Inc. Toxoplasma IgM by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI 2a26fc93-26f5-4aac-8d9d-eb25ae07f3a9 37 fields · synced Jun 1, 2026