The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II assay.

The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II assay.
Access Toxo IgM II QC - 34479

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.

No Data Available

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: 15099590624781

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