Simplexa™ HSV 1 & 2 Direct

Simplexa™ HSV 1 & 2 Direct - MOL2150

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).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PGH

Device Name: Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Device Class: 2

Physical State: Reagent Assay Kit and Instrument

Definition: Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Real-time Polymerase Chain Reaction Assay

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not Applicable, the device is an In vitro diagnostic device

Regulation Number: 866.3307

Third Party Flag: N

Medical Specialty: MI

Device Id: 20816101025507

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