AmpliVue CDiff Assay

AmpliVue CDiff Assay
AmpliVue - C. difficile Assay

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to one or multiple virus serotypes from within the enterovirus family, in a clinical specimen. Enteroviruses intended to be detected may include Coxsackie viruses subgroups A and B, polioviruses, echoviruses and/or enteroviruses type 68-71.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OZN

Device Name: C. Difficile Toxin Gene Amplification Assay

Device Class: 2

Physical State: Not applicable

Definition: Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses amplification technology to detect toxin genes of C. difficile

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not applicable

Regulation Number: 866.3130

Third Party Flag: N

Medical Specialty: MI

Device Id: 30014613312017

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