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, Opiates (DJG) (6) Enzyme Immunoassay, Cannabinoids (LDJ) (6) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (6) Thin Layer Chromatography, Methamphetamine (DJC) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1)

Premarket Exempt

No Yes

Clear

QuickProfile™ PCP Test Card - M90107RD70220 Catalog Number : 07RD7022

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

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD7061010 Catalog Number : 07RD7061-01

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DIO, LDJ

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD706102A0 Catalog Number : 07RD7061-02A

Device Description : Immunoassay for the detection of the following drug substance(s) in human urine: Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-2000

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJG, DJC

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD7061030 Catalog Number : 07RD7061-03

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : LDJ, DJC

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD706104A0 Catalog Number : 07RD7061-04A

Device Description : Immunoassay for the detection of the following drug substance(s) in human urine: Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : JXM, DJG

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 3 Test - M90107RD7062020 Catalog Number : 07RD7062-02

Device Description : Immunoassay for the detection of the following drug substance(s) in human urine: Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : LDJ, DJC, DIO

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 3 Test - M90107RD7062040 Catalog Number : 07RD7062-04

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 4 Test - M90107RD7063010 Catalog Number : 07RD7063-01

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DKZ, LDJ, DIO, DJG

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 4 Test - M90107RD7063020 Catalog Number : 07RD7063-02

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJC, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 4 Test - M90107RD7063030 Catalog Number : 07RD7063-03

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : JXM, DJR, DIO, DJG

Prescription Use : Yes

Device Count : 1

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