- Physicians Office Resource

ToRC IgG Reagent Pack
BioPlex 2200 - 6651650

Device Description

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 a fluorescent immunoassay method.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

100 Number of Tests

100 Number of Tests

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OMI

Device Name: Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

Device Class: 2

Physical State: The device is a fully automated instrument.

Definition: The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device utilizes multiplex immunofluorescence technology to assess the presence of IgG antibodies for each of the analytes in the panel in a single sample by binding to antigen-coated fluoromagnetic beads with unique fluorescent signatures.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Assay

Regulation Number: 866.3510

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 00847865000444

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

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