Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi
Pointe Scientific, Inc. Toxoplasma IgG - T8001-96

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LGD

Device Name: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3780

Third Party Flag: Y

Medical Specialty: MI

Device Id: 00811727015150

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A