LifeSign QuikScreen 11

GUDID 20863480002100

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 L.L.C.

Drug/toxicology adulteration IVD, kit, enzyme spectrophotometry, rapid

• Primary Device ID: 20863480002100
• NIH Device Record Key: 8300f52e-0d02-4ace-9b70-b0771deec64e
• Commercial Distribution Discontinuation: 2016-09-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LifeSign QuikScreen 11
• Version Model Number: 60B02
• Company DUNS: 010964864
• Company Name: Lifesign L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863480002106 [Primary]
GS1	10863480002103 [Package]; Contains: 00863480002106; Package: Kit Box [25 Units]; Discontinued: 2013-02-01; Not in Commercial Distribution
GS1	20863480002100 [Package]; Contains: 10863480002103; Package: Shipper Box [4 Units]; Discontinued: 2013-02-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071489

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-26
• Device Publish Date: 2016-09-24

Devices Manufactured by Lifesign L.L.C.

• 20863480002100 - LifeSign QuikScreen 11: 2020-03-26LifeSign 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
• 20863480002100 - LifeSign QuikScreen 11: 2020-03-26 LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/ml Phencyclidine (PCP) 25 ng/ml Methamphetamine (MET) 1000 ng/ml Opiate (OPI)
• 20863480002117 - Status Toxi Cup 13+4: 2020-03-26 Status Toxi-Cup 13 panel drug cup with 4 adulterants: AMP1000 BAR300 COC300 THC50 MAD300 MET1000 MDMA500 OPI2000 OXY100 PCP25 TC
• 00868348000201 - Status ASSURE: 2018-07-06 (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
• 00868348000218 - Status ASSURE: 2018-07-06 (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
• 00868348000225 - Status ASSURE: 2018-07-06 MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
• 00868348000232 - Status ASSURE: 2018-07-06 MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
• 00868348000249 - Status ASSURE: 2018-07-06 AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup
• 10868348000253 - Status Toxi Cup: 2018-07-06 Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 100