FDA.reportPublic FDA data

Anti-T. gondii IgG

Primary DI
00845533003360
Brand
Anti-T. gondii IgG
Company
ZEUS SCIENTIFIC, INC.
Model
SM8Z8651G
Catalog number
SM8Z8651G
Device description
The Anti-T. gondii IgG is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533003360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533003360008455330033608455330033600845533003360

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
080953946
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00845533003582Alegria Flash SSA-60CL28001CL280012026-06-08
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00845533003612Alegria Flash SSA-52 Control KitCL28011CKCL28011CK2026-06-08
00845533003629Alegria Flash SSBCL28021CL280212026-06-08
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00845533003674Herpes Simplex Virus-2 (HSV-2) IgMFA9052MFA9052M2026-06-08
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00845533003483Striated Muscle (Rat)5848RL5848RL2026-05-15
00845533003490Alegria Flash PR3CL28141CL281412026-05-15
00845533003506Alegria Flash PR3 Control KitCL28141CKCL28141CK2026-05-15
00845533003513Alegria Flash MPO CL28131CL281312026-05-15
00845533003520Alegria Flash MPO Control KitCL28131CKCL28131CK2026-05-15