EXPRESS DIAGNOSTICS 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, Cannabinoids (LDJ) (4) Enzyme Immunoassay, Opiates (DJG) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Amphetamine (DKZ) (3) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (3) Enzyme Immunoassay, Methadone (DJR) (3) Gas Chromatography, Methamphetamine (LAF) (3) Enzyme Immunoassay, Phencyclidine (LCM) (2) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2) Enzyme Immunoassay, Barbiturate (DIS) (2) Test, Methamphetamine, Over The Counter (NGG) (1) Test, Amphetamine, Over The Counter (NFT) (1) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (1)

Premarket Exempt

Clear

DrugCheck - B2986552050 Catalog Number : 65520-5

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

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck - B2987113030 Catalog Number : 71130-3

Device Description : 11 Panel Cup Drug Test, AMP500-BUP-BZO-COC150-EDDP300-MDMA-MET500-MTD-OPI300-OXY 11 Panel Cup Drug Test, AMP500-BUP-BZO-COC150-EDDP300-MDMA-MET500-MTD-OPI300-OXY-THC-pH,SG,OX

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck Waive - B298DC8121050 Catalog Number : DC 81210-5

Device Description : DrugCheck Waive 12 Panel Cup Test, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MD DrugCheck Waive 12 Panel Cup Test, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugCheck Waive - B298DCC8120550 Catalog Number : DCC-81205-5

Device Description : DrugCheck Waive 12 Panel Cup Test, (BZO/BAR)+(COC/THC)+(MET/OPI)+(MTD/TCA)+(OXY/ DrugCheck Waive 12 Panel Cup Test, (BZO/BAR)+(COC/THC)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) With Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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