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

No Yes

Clear

Detectabuse - 00850004812792 Catalog Number : 19470012

Device Description : Negative Urine Control with Stabilizer, 1L

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812808 Catalog Number : 19470010-10pk

Device Description : MDMA, OXY, BUP, Cutoff -50%, 10x5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812815 Catalog Number : 19470011-10pk

Device Description : MDMA, OXY, BUP, Cutoff +50%, 10x5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812822 Catalog Number : 19470051

Device Description : STAT-SKREEN, Cutoff +50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812839 Catalog Number : 19470052

Device Description : STAT-SKREEN, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812846 Catalog Number : 19470053

Device Description : STAT-SKREEN, Cutoff +25%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812853 Catalog Number : 19470054

Device Description : STAT-SKREEN, Cutoff -25%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812860 Catalog Number : 19470070

Device Description : STAT-SKREEN-H, Cutoff +50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812877 Catalog Number : 19470055

Device Description : STAT-SKREEN, 3X Cutoff, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812884 Catalog Number : 19470071

Device Description : STAT-SKREEN-H, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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