The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.
Evidence MultiSTAT DOA Urine MultiPlex - EV4393
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen, using a multiplex method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DIS
Device Name: Enzyme Immunoassay, Barbiturate
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.3150
Third Party Flag: Y
Medical Specialty: TX
Code: DJG
Device Name: Enzyme Immunoassay, Opiates
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.3650
Third Party Flag: Y
Medical Specialty: TX
Code: LCM
Device Name: Enzyme Immunoassay, Phencyclidine
Device Class: U
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: 1
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 05055273216752
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