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, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Barbiturate (DIS) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (2) Enzyme Immunoassay, Opiates (DJG) (2)

Premarket Exempt

Clear

DrugCheck - B298301300 Catalog Number : 30130

Device Description : Single Dip Drug Test, COC

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

DrugCheck - B29830130C0 Catalog Number : 30130C

Device Description : Single Dip Cassette Drug Test, COC

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

DrugCheck - B298301350 Catalog Number : 30135

Device Description : Single Dip Drug Test, COC150

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

DrugCheck - B29830135C0 Catalog Number : 30135C

Device Description : Single Dip Cassette Drug Test, COC150

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

DrugCheck - B298301400 Catalog Number : 30140

Device Description : Single Dip Drug Test, THC

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : LDJ

Prescription Use : No

Device Count : 1

DrugCheck - B29830140C0 Catalog Number : 30140C

Device Description : Single Dip Cassette Drug Test, THC

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : LDJ

Prescription Use : No

Device Count : 1

DrugCheck - B298301500 Catalog Number : 30150

Device Description : Single Dip Drug Test, BAR

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DIS

Prescription Use : No

Device Count : 1

DrugCheck - B29830150C0 Catalog Number : 30150C

Device Description : Single Dip Cassette Drug Test, BAR

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DIS

Prescription Use : No

Device Count : 1

DrugCheck - B298301600 Catalog Number : 30160

Device Description : Single Dip Drug Test, OPI

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

DrugCheck - B29830160C0 Catalog Number : 30160C

Device Description : Single Dip Cassette Drug Test, OPI

Device Class : 2

Duns Number: 168560402

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

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