Anti-T. gondii IgM SM8Z8651M

GUDID 00845533002547

The Anti-T. gondii IgM is an enzyme-linked immunosorbent assay designed for the presumptive qualitative detection of IgM antibodies to Toxoplasmaplasma gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive Toxoplasma gondii infection. To adequately assess the patient’s serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This product is not FDA cleared (approved) for use in screening blood or plasma donors. This assay’s performance has not been established for screening of prenatal women or newborns.

ZEUS SCIENTIFIC, INC.

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533002547
• NIH Device Record Key: 5f45a00e-ce6a-4289-aa00-ac1df475676a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-T. gondii IgM
• Version Model Number: SM8Z8651M
• Catalog Number: SM8Z8651M
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533002547 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-25
• Device Publish Date: 2025-12-17

On-Brand Devices [Anti-T. gondii IgM]

• 00845533002547: The Anti-T. gondii IgM is an enzyme-linked immunosorbent assay designed for the presumptive qual
• 00845533002516: The Anti-T. gondii IgM is an enzyme-linked immunosorbent assay designed for the presumptive qual