Express Diagnostic Int'l, Inc.

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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, Opiates (DJG) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Gas Chromatography, Methamphetamine (LAF) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (9) Enzyme Immunoassay, Methadone (DJR) (9) Enzyme Immunoassay, Phencyclidine (LCM) (9) Enzyme Immunoassay, Amphetamine (DKZ) (9) Enzyme Immunoassay, Barbiturate (DIS) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (9) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (8) Enzyme Immunoassay, Propoxyphene (JXN) (4) Test, Amphetamine, Over The Counter (NFT) (1) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (1) Test, Methamphetamine, Over The Counter (NGG) (1)

Premarket Exempt

No Yes

Clear

DrugCheck - B2986130750 Catalog Number : 61307-5

Device Description : 13 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC-pH 13 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC-pH,SG,OX-CR,NI

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck - B2986131350 Catalog Number : 61313-5

Device Description : DrugCheck NxStep OnSite Drug Test, AMP500-BARB-BUP-BZO-COC150-MDMA-MET500-MTD-OP DrugCheck NxStep OnSite Drug Test, AMP500-BARB-BUP-BZO-COC150-MDMA-MET500-MTD-OPI300-OXY-PCP-TCA-THC-pH,SG,OX-CR,NI

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : NFT, DIS, DJG, JXM, NFY, LAF, NGG, DJR, LCM, LFG, LDJ

Prescription Use : No

Device Count : 1

DrugCheck - B298613290 Catalog Number : 61329

Device Description : DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-TCA-THC

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : JXM, DKZ, DIS, DJG, DIO, LAF, DJR, LCM, JXN, LFG, LDJ

Prescription Use : No

Device Count : 1

DrugCheck - B2986133010 Catalog Number : 61330

Device Description : 13 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-TCA-THC

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck - B2986140010 Catalog Number : 61400

Device Description : DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-PPX-TCA-THC

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck - B298614070 Catalog Number : 61407

Device Description : DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY- DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-TCA-THC

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : LDJ, LFG, JXN, LCM, DJR, LAF, DIO, JXM, DJG, DIS, DKZ

Prescription Use : No

Device Count : 1

DrugCheck - B2986140730 Catalog Number : 61407-3

Device Description : DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY- DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-TCA-THC-pH,SG,OX

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : JXM, DKZ, DIS, DJG, DIO, LAF, DJR, LCM, JXN, LFG, LDJ

Prescription Use : No

Device Count : 1

DrugCheck - B298614100 Catalog Number : 61410

Device Description : DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-EDDP-MDMA-MET-MTD-OPI-OX DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-EDDP-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck - B298614130 Catalog Number : 61413

Device Description : DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-EDDP-MDMA-MET-MTD-OPI300 DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-EDDP-MDMA-MET-MTD-OPI300-OXY-PCP-TCA-THC

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck - B29865500310 Catalog Number : 65500-3

Device Description : 5 Panel Cup Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : LDJ, DJG, LAF, DIO, DKZ

Prescription Use : No

Device Count : 1

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