LUMIQUICK DIAGNOSTICS, INC.

Address:2946 SCOTT BLVD.,SANTA CLARA,CA,95054,US

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Filters

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) (2) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Enzyme Immunoassay, Methadone (DJR) (2) Thin Layer Chromatography, Barbiturate (DKX) (2) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1)

Premarket Exempt

No Yes

Clear

QuickProfile™ Opiate Test Card - M90107RD70120 Catalog Number : 07RD7012

Device Description : Immunoassay for the detection of opiate in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

QuickProfile™ Amphetamine Test Strip - M90107RD70130 Catalog Number : 07RD7013

Device Description : Immunoassay for the detection of amphetamine in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

QuickProfile™ Amphetamine Test Card - M90107RD70140 Catalog Number : 07RD7014

Device Description : Immunoassay for the detection of amphetamine in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

QuickProfile™ Barbiturate Test Strip - M90107RD70150 Catalog Number : 07RD7015

Device Description : Immunoassay for the detection of barbiturate in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DKX

Prescription Use : Yes

Device Count : 1

QuickProfile™ Barbiturate Test Card - M90107RD70160 Catalog Number : 07RD7016

Device Description : Immunoassay for the detection of barbiturate in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DKX

Prescription Use : Yes

Device Count : 1

QuickProfile™ Benzodiazepine Test Strip - M90107RD70170 Catalog Number : 07RD7017

Device Description : Immunoassay for the detection of benzodiazepine in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

QuickProfile™ Benzodiazepine Test Card - M90107RD70180 Catalog Number : 07RD7018

Device Description : Immunoassay for the detection of benzodiazepine in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

QuickProfile™ Methadone Test Strip - M90107RD70190 Catalog Number : 07RD7019

Device Description : Immunoassay for the detection of methadone in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

QuickProfile™ Methadone Test Card - M90107RD70200 Catalog Number : 07RD7020

Device Description : Immunoassay for the detection of methadone in human urine

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

QuickProfile™ PCP Test Strip - M90107RD70210 Catalog Number : 07RD7021

Device Description : Immunoassay for the detection of PCP in human urine

Device Class : U

Duns Number: 790175165

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

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