BIOCHEMICAL DIAGNOSTICS INC

Address:180 HEARTLAND BLVD.,Edgewood,NY,11717,US

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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

Drug Mixture Control Materials (DIF) (10)

Premarket Exempt

Yes No

Clear

Detectabuse - 00810042680210 Catalog Number : 18002142

Device Description : SAMHSA Plus, Low Control, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680227 Catalog Number : 18002143

Device Description : SAMHSA Plus, High Control, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680234 Catalog Number : 18002144

Device Description : NON-MANDATED Low, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680241 Catalog Number : 18002145

Device Description : NON-MANDATED High, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680258 Catalog Number : 18002490

Device Description : OXY/MDMA/EDDP, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680265 Catalog Number : 18002491

Device Description : OXY/MDMA/EDDP, Cutoff+50, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

DETECTABUSE - 00810042680272 Catalog Number : 18002743

Device Description : Combo-H, +50%, 20ml

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : No

Device Count : 1

Detectabuse - 00810042680289 Catalog Number : 18002907

Device Description : 9 Panel Cutoff -/+ 25%, 5ML KITBOX

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680296 Catalog Number : 18002908

Device Description : 9 Panel CUTOFF 5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680302 Catalog Number : 18002953

Device Description : Cobas DAU, Cutoff +25%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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