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 - 00850004812587 Catalog Number : 19466908-6pk

Device Description : SERIES VI 3X CUTOFF, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812594 Catalog Number : 19332001-10pk

Device Description : GC/MS CUTOFF -25%, 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812600 Catalog Number : 19582126-10pk

Device Description : CONFIRM 4, CUTOFF +25%, 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812617 Catalog Number : 19582026-10pk

Device Description : CONFIRM 4 CUTOFF -25%, 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812624 Catalog Number : 19572753-10pk

Device Description : GC/MS-H CUTOFF +25%, 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812631 Catalog Number : 19572251-10pk

Device Description : GC/MS-H CUTOFF -25%,10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812648 Catalog Number : 19332501-10pk

Device Description : GC/MS CUTOFF +25%, 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812655 Catalog Number : 19227000-10pk

Device Description : Negative Urine Control 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812662 Catalog Number : 19582002-10pk

Device Description : Confirm 4, Cutoff 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812679 Catalog Number : 18002842-6pk

Device Description : Combo-H, Cutoff -50%, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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