Express Diagnostic Int'l, Inc.

Express Diagnostic 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, Amphetamine (DKZ) (2) Enzyme Immunoassay, Methadone (DJR) (2) Enzyme Immunoassay, Opiates (DJG) (2) Gas Chromatography, Methamphetamine (LAF) (2) Test, Amphetamine, Over The Counter (NFT) (1) Test, Methamphetamine, Over The Counter (NGG) (1)

Premarket Exempt

No Yes

Clear

DrugCheck - B29830100C10 Catalog Number : 30100C

Device Description : Single Dip Cassette Drug Test, MTD

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : DJR

Prescription Use : No

Device Count : 1

DrugCheck - B2983011010 Catalog Number : 30110

Device Description : Single Dip Drug Test, AMP

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : DKZ

Prescription Use : No

Device Count : 1

DrugCheck - B29830110C10 Catalog Number : 30110C

Device Description : DrugCheck Single Dip Cassette Drug Test, AMP

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : DKZ

Prescription Use : No

Device Count : 1

DrugCheck - B2983011110 Catalog Number : 30111

Device Description : Single Dip Drug Test, OXY

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

DrugCheck - B29830111C10 Catalog Number : 30111C

Device Description : Single Dip Cassette Drug Test, OXY

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

DrugCheck - B298301150 Catalog Number : 30115

Device Description : Single Dip Drug Test, AMP500

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : NFT

Prescription Use : No

Device Count : 1

DrugCheck - B2983012010 Catalog Number : 30120

Device Description : Single Dip Drug Test, MET

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : LAF

Prescription Use : No

Device Count : 1

DrugCheck - B29830120C10 Catalog Number : 30120C

Device Description : Single Dip Cassette Drug Test, MET

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : LAF

Prescription Use : No

Device Count : 1

DrugCheck - B2983012510 Catalog Number : 30125

Device Description : Single Dip Drug Test, MET500

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : NGG

Prescription Use : No

Device Count : 1

DrugCheck - B29830128C10 Catalog Number : 30128C

Device Description : Single Dip Cassette Drug Test, EDDP

Device Class : 2

Duns Number: 015875273

Premarket Exempt : No

Product Code : DJR

Prescription Use : No

Device Count : 1

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