HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and other materials intended to be used for the qualitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT). This is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV
HSV 1&2 ELITe MGB Assay - M800584
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT).
Environmental Conditions
- -15.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 03661540950025
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