LUMIQUICK DIAGNOSTICS, INC.

Address:2946 SCOTT BLVD.,SANTA CLARA,CA,95054,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) (2) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

No Yes

Clear

QuickProfile™ Amphetamine Test Card - M90174014 Catalog Number : 74014

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

Device Class :

Duns Number: 790175165

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Test Cup - M90174046II0 Catalog Number : 74046-II

Device Description : Immunoassay for the detection of the following drug substance(s) in human urine:

Device Class :

Duns Number: 790175165

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

QuickProfile™ HCG Test Card - M901W1C0 Catalog Number : W1-C

Device Description : immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)

Device Class :

Duns Number: 790175165

Premarket Exempt : No

Product Code : LCX

Prescription Use : Yes

Device Count : 1

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