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) (9) Multi-Analyte Controls Unassayed (OHQ) (1)

Premarket Exempt

No Yes

Clear

Detectabuse - 00850004812488 Catalog Number : 19003066-6PK

Device Description : STAT-SKREEN17 POSITIVE CONTROL, 6x10mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812495 Catalog Number : 19003081-6PK

Device Description : STAT-SKREEN17H URINE POSITIVE CONTROL, 6x10mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Adulter-Skreen - 00850004812501 Catalog Number : 20300002

Device Description : ADULTER-SKREEN DOA Urine Validity Controls

Device Class : 1

Duns Number: 028007698

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Detectabuse - 00850004812518 Catalog Number : 19000010-6PK

Device Description : Negative Urine Control 10x5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812525 Catalog Number : 19900025-2pk

Device Description : ETHYL GLUCURONIDE 250ng/mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812532 Catalog Number : 19900050-2pk

Device Description : ETHYL GLUCURONIDE 500ng/mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812549 Catalog Number : 19601059-6pk

Device Description : SERIES XV-H 3X CUTOFF 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812556 Catalog Number : 19601908-6pk

Device Description : SERIES X-H, 3X CUTOFF, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812563 Catalog Number : 19544756-6pk

Device Description : SERIES IV-H CUTOFF+25%, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812570 Catalog Number : 19544252-6pk

Device Description : SERIES IV-H CUTOFF -25%, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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