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 - 00850004812686 Catalog Number : 18002743-6pk

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

Detectabuse - 00850004812693 Catalog Number : 18002844-6pk

Device Description : Combo-H, 3X Cutoff, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812709 Catalog Number : 18003087-6pk

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

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812723 Catalog Number : 18003089-6pk

Device Description : Combo-U, 3X Cutoff, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812730 Catalog Number : 18003090-6pk

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

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812747 Catalog Number : 18003091-6pk

Device Description : Combo-A, Cutoff +50%, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812754 Catalog Number : 18003092-6pk

Device Description : Combo-A, 3X Cutoff, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812761 Catalog Number : 19227005

Device Description : Negative Urine Control, 500mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812778 Catalog Number : 19227010

Device Description : Negative Urine Control, 1L

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812785 Catalog Number : 19470006

Device Description : Negative Urine Control with Stabilizer, 500mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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