LifeSign QuikScreen 11:
Amphetamine (AMP) 1000 ng/ml
Phencyclidine (PCP) 25 ng/ml
Methamphetamine (MET) 1000 ng/ml
Opiate (OPI) 2000 ng/ml
Barbiturates (BAR) 300 ng/ml
Benzodiazepine (BZD) 300 ng/ml
Marijuana (THC) 50 ng/ml
Methadone (MAD) 300 ng/ml
Oxycodone (OXY) 100 ng/ml
Tricyclic Antidepressants (TCA) 1000 ng/ml
Cocaine (COC) 300ng/ml
LifeSign QuikScreen 11 - 60B02
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: LFH
Device Name: U.V. Spectrometry, Tricyclic Antidepressant Drugs
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: 862.3910
Third Party Flag: Y
Medical Specialty: TX
Code: DJR
Device Name: Enzyme Immunoassay, Methadone
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: 862.3620
Third Party Flag: Y
Medical Specialty: TX
Code: DJC
Device Name: Thin Layer Chromatography, Methamphetamine
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: 862.3610
Third Party Flag: Y
Medical Specialty: TX
Code: LDJ
Device Name: Enzyme Immunoassay, Cannabinoids
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: 862.3870
Third Party Flag: Y
Medical Specialty: TX
Code: DIO
Device Name: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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: 862.3250
Third Party Flag: Y
Medical Specialty: TX
Code: JXM
Device Name: Enzyme Immunoassay, Benzodiazepine
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: 862.3170
Third Party Flag: Y
Medical Specialty: TX
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: DKZ
Device Name: Enzyme Immunoassay, Amphetamine
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: 862.3100
Third Party Flag: Y
Medical Specialty: TX
Device IdentifiersDevice Id: 20863480002100
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10863480002103
Package Quantity: 4
Package Discontinue Date: 2/1/2013 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Shipper Box
Device Id: 10863480002103
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00863480002106
Package Quantity: 25
Package Discontinue Date: 2/1/2013 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Kit Box
Device Id: 00863480002106
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