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.

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Primary Device ID20863480002100
NIH Device Record Key8300f52e-0d02-4ace-9b70-b0771deec64e
Commercial Distribution Discontinuation2016-09-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLifeSign QuikScreen 11
Version Model Number60B02
Company DUNS010964864
Company NameLifesign L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100863480002106 [Primary]
GS110863480002103 [Package]
Contains: 00863480002106
Package: Kit Box [25 Units]
Discontinued: 2013-02-01
Not in Commercial Distribution
GS120863480002100 [Package]
Contains: 10863480002103
Package: Shipper Box [4 Units]
Discontinued: 2013-02-01
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-26
Device Publish Date2016-09-24

Devices Manufactured by Lifesign L.L.C.

20863480002100 - LifeSign QuikScreen 112020-03-26LifeSign 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 112020-03-26 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+42020-03-26 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 ASSURE2018-07-06 (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 ASSURE2018-07-06 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 ASSURE2018-07-06 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 ASSURE2018-07-06 AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup
10868348000253 - Status Toxi Cup2018-07-06 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
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