EXPRESS DIAGNOSTICS INT'L, INC.

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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, Benzodiazepine (JXM) (2) Enzyme Immunoassay, Opiates (DJG) (2) Enzyme Immunoassay, Phencyclidine (LCM) (2) Gas Chromatography, Methamphetamine (LAF) (2) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2)

Premarket Exempt

Clear

DrugCheck - B298301630 Catalog Number : 30163

Device Description : Single Dip Drug Test, OPI300

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

DrugCheck - B29830163C0 Catalog Number : 30163C

Device Description : Single Dip Cassette Drug Test, OPI300

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

DrugCheck - B298301700 Catalog Number : 30170

Device Description : Single Dip Drug Test, BZO

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : JXM

Prescription Use : No

Device Count : 1

DrugCheck - B29830170C0 Catalog Number : 30170C

Device Description : Single Dip Cassette Drug Test, BZO

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : JXM

Prescription Use : No

Device Count : 1

DrugCheck - B298301800 Catalog Number : 30180

Device Description : Single Dip Drug Test, PCP

Device Class : U

Duns Number: 168560402

Premarket Exempt : No

Product Code : LCM

Prescription Use : No

Device Count : 1

DrugCheck - B29830180C0 Catalog Number : 30180C

Device Description : Single Dip Cassette Drug Test, PCP

Device Class : U

Duns Number: 168560402

Premarket Exempt : No

Product Code : LCM

Prescription Use : No

Device Count : 1

DrugCheck - B298301850 Catalog Number : 30185

Device Description : Single Dip Drug Test, TCA

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : LFG

Prescription Use : No

Device Count : 1

DrugCheck - B29830185C0 Catalog Number : 30185C

Device Description : Single Dip Cassette Drug Test, TCA

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : LFG

Prescription Use : No

Device Count : 1

DrugCheck - B298301900 Catalog Number : 30190

Device Description : Single Dip Drug Test, MDMA

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : LAF

Prescription Use : No

Device Count : 1

DrugCheck - B29830190C0 Catalog Number : 30190C

Device Description : Single Dip Cassette Drug Test, MDMA

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : LAF

Prescription Use : No

Device Count : 1

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