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 - 00850004812273 Catalog Number : 19447252-6pk

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

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812280 Catalog Number : 19447756-6pk

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

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812297 Catalog Number : 19458756-6pk

Device Description : SERIES V CUTOFF +25%, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812303 Catalog Number : 19458252-6pk

Device Description : SERIES V CUTOFF -25%, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812310 Catalog Number : 19466252-6pk

Device Description : SERIES VI CUTOFF -25%, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812327 Catalog Number : 19466756-6pk

Device Description : SERIES VI CUTOFF +25%

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812334 Catalog Number : 19601057-6pk

Device Description : SERIES XV-H CUTOFF -25%

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812341 Catalog Number : 19601058-6pk

Device Description : SERIES XV-H CUTOFF +25%

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812365 Catalog Number : 702002

Device Description : Kova tox, DOA-SKREEN-H, Negative and Positive Urine Control, 10mL kitbox

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812372 Catalog Number : 702004

Device Description : Kova tox, STAT-SKREEN 17H Negative and Positive 10mL Kitbox

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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