Lifesign L.L.C.

Address:85 Orchard Rd,Skillman,NJ,08558,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Immunoassay, Amphetamine (DKZ) (8) Enzyme Immunoassay, Cannabinoids (LDJ) (8) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (8) Enzyme Immunoassay, Opiates (DJG) (8) Thin Layer Chromatography, Methamphetamine (DJC) (8) Enzyme Immunoassay, Barbiturate (DIS) (7) Enzyme Immunoassay, Phencyclidine (LCM) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (7) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (4) Gas Chromatography, Methamphetamine (LAF) (4) U.V. Spectrometry, Tricyclic Antidepressant Drugs (LFH) (3) Enzyme Immunoassay, Methadone (DJR) (1)

Premarket Exempt

Clear

LifeSign QuikScreen 11 - 00863480002106 Catalog Number :

Device Description : LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : DJG, LFH, DJR, DJC, LDJ, DIO, JXM, DIS, DKZ

Prescription Use : No

Device Count : 1

Status Toxi Cup 13+4 - 00863480002113 Catalog Number :

Device Description : Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : LFH, LCM, DJG, DJC, DIO, LDJ, JXM, DIS, DKZ

Prescription Use : No

Device Count : 1

Status ASSURE - 00868348000201 Catalog Number : 11125AA

Device Description : (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : LFG, DJC, DKZ, LCM, LAF, DJG, LDJ, DIO, DIS, JXM

Prescription Use : Yes

Device Count : 1

Status ASSURE - 00868348000218 Catalog Number : 11125AA2K

Device Description : (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : LFG, DJC, DKZ, LCM, LAF, DJG, LDJ, DIO, DIS, JXM

Prescription Use : Yes

Device Count : 1

Status ASSURE - 00868348000225 Catalog Number : 71125AA

Device Description : MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : DKZ, LCM, LAF, LDJ, DIO, DIS, JXM, LFG, DJG, DJC

Prescription Use : Yes

Device Count : 1

Status ASSURE - 00868348000232 Catalog Number : 71125AA2K

Device Description : MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : DKZ, LCM, LAF, LDJ, DIO, DIS, JXM, LFG, DJG, DJC

Prescription Use : Yes

Device Count : 1

Status ASSURE - 00868348000249 Catalog Number : 76025AA2K

Device Description : AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : LDJ, LCM, DJG, DJC, DIO, DKZ

Prescription Use : Yes

Device Count : 1

Status Toxi Cup - 00868348000256 Catalog Number :

Device Description : Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 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 1000, OPI 2000, OXY 100, PCP 25, TCA 1000, THC 50 + pH/CRE/NBP/SG

Device Class : 2

Duns Number: 010964864

Premarket Exempt : No

Product Code : LFH, LCM, DJG, DJC, DIO, LDJ, JXM, DIS, DKZ

Prescription Use : No

Device Count : 1

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