Alinity m HSV 1 & 2 / VZV CTRL Kit

Alinity m HSV 1 & 2 / VZV CTRL Kit
Alinity m - 09N61-085

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple human herpesviruses in a clinical specimen. Viruses detected may include (but not limited to) herpes simplex virus 1 (HSV1), herpes simplex virus 2 (HSV2) and/or varicella-zoster virus (VZV).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PGI

Device Name: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Device Class: 2

Physical State: Reagent assay kit and instrument

Definition: For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Polymerase chain reaction

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not Applicable. In vitro diagnostic device

Regulation Number: 866.3309

Third Party Flag: N

Medical Specialty: MI

Device Id: 00884999050587

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