Simplexa™ VZV Positive Control Pack - MOL3660
Device Description
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 varicella-zoster virus (VZV) in a clinical specimen.
Environmental Conditions
- -10.00
- -30.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PLO
Device Name: Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device Class: 2
Physical State: Meningitis/encephalitis pathogen multiplex nucleic acid detection systems are in vitro devices that consist of reagents and associated instrumentation for detection and identification of microbial nucleic acids in cerebrospinal fluid specimens.
Definition: A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A qualitative in vitro diagnostic assay that detects and identifies microbial-associated nucleic acids in cerebrospinal fluid specimens.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: In vitro diagnostic device
Regulation Number: 866.3970
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 20816101025781
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