NEXSCREEN, LLC

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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

Thin Layer Chromatography, Methamphetamine (DJC) (5) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (5) Enzyme Immunoassay, Opiates (DJG) (5) Enzyme Immunoassay, Amphetamine (DKZ) (5) Enzyme Immunoassay, Phencyclidine (LCM) (2) Enzyme Immunoassay, Methadone (DJR) (2) Enzyme Immunoassay, Barbiturate (DIS) (2) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (2)

Premarket Exempt

Clear

NexScreen Drug Dip Card - 00858984006309 Catalog Number : NCard-09-01

Device Description : NexScreen Drug Dip Card 9 PanelCOC150/THC50/OPI2000/AMP500/MET500/PCP25/BZO300/B NexScreen Drug Dip Card 9 PanelCOC150/THC50/OPI2000/AMP500/MET500/PCP25/BZO300/BAR300/MTD300

Device Class : 2

Duns Number: 031433133

Premarket Exempt : No

Product Code : DJC, DIO, DKZ, DJG

Prescription Use : Yes

Device Count : 1

NexScreen Drug Dip Card - 00858984006316 Catalog Number : NCard-12-BUP

Device Description : NexScreen Drug Dip Card 9 PanelCOC150/THC50/OPI2000/AMP500/MET500/PCP25/BZO300/B NexScreen Drug Dip Card 9 PanelCOC150/THC50/OPI2000/AMP500/MET500/PCP25/BZO300/BAR300/MTD300

Device Class : 2

Duns Number: 031433133

Premarket Exempt : No

Product Code : DJG, DKZ, DIO, DJC

Prescription Use : Yes

Device Count : 1

NexScreen Drug Dip Card - 00858984006323 Catalog Number : NCard-12-PPX

Device Description : NexScreen Drug Dip Card 12 Panel (PPX)BZO300/BAR300/COC150/THC50/MET500/OPI2000/ NexScreen Drug Dip Card 12 Panel (PPX)BZO300/BAR300/COC150/THC50/MET500/OPI2000/MTD300/OXY100/MDMA500/PCP25/AMP500/PPX300

Device Class : 2

Duns Number: 031433133

Premarket Exempt : No

Product Code : DJC, DIO, DKZ, DJG

Prescription Use : Yes

Device Count : 1

NexScreen Drug Screen Cup with AD - 00858984006330 Catalog Number : NCard-12+4

Device Description : AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)

Device Class : 2

Duns Number: 031433133

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

NexScreen Drug Screen Cup - 00858984006347 Catalog Number : NCard-12

Device Description : AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50

Device Class : 2

Duns Number: 031433133

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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