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, Cocaine And Cocaine Metabolites (DIO) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Opiates (DJG) (2) Thin Layer Chromatography, Methamphetamine (DJC) (2) Visual, Pregnancy Hcg, Prescription Use (JHI) (1) Coronavirus Antigen Detection Test System. (QKP) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1)

Premarket Exempt

No Yes

Clear

Rapid SARS-CoV-2 Antigen Test Card - 00855636003716 Catalog Number : 1N40C5-1-US-BS

Device Description : The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chroma The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.

Device Class :

Duns Number: 790175165

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : No

Device Count : 1

QuickProfile™ Drugs of Abuse Panel 6 Test - M09107RD7065220 Catalog Number : 07RD7065-22

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: BUP / BZD / COC / OPI / OXY / THC

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : JXM, DIO, LDJ, DJG

Prescription Use : Yes

Device Count : 1

QuickProfile™ HCG Test Strip - M90107RD70010 Catalog Number : 07RD7001

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

QuickProfile™ Methamphetamine Test Strip - M90107RD70050 Catalog Number : 07RD7005

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

QuickProfile™ Methamphetamine Test Card - M90107RD70060 Catalog Number : 07RD7006

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

Device Class :

Duns Number: 790175165

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

QuickProfile™ Cocaine Test Strip - M90107RD70070 Catalog Number : 07RD7007

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

QuickProfile™ Cocaine Test Card - M90107RD70080 Catalog Number : 07RD7008

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

QuickProfile™ THC Test Strip - M90107RD70090 Catalog Number : 07RD7009

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

QuickProfile™ THC Test Card - M90107RD70100 Catalog Number : 07RD7010

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

Device Class : 2

Duns Number: 790175165

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

QuickProfile™ Opiate Test Strip - M90107RD70110 Catalog Number : 07RD7011

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

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