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 - 00850004812075 Catalog Number : 19223011-6PK

Device Description : Negative Urine Control 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812082 Catalog Number : 18007774

Device Description : Specialty Diagnostix Panel 1, 2x5mL Kitbox

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812099 Catalog Number : 18007751

Device Description : Specialty Diagnostix Panel 2, 2x5mL Kitbox

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812105 Catalog Number : 19499756-6pk

Device Description : SERIES IX, CUTOFF +25%

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812112 Catalog Number : 19499252-6pk

Device Description : SERIES IX, CUTOFF -25%

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812129 Catalog Number : 19601056-6pk

Device Description : SERIES X-H, CUTOFF +25%

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812136 Catalog Number : 19601052-6pk

Device Description : SERIES X-H, CUTOFF -25%

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812143 Catalog Number : 702003

Device Description : Kova tox, STAT-SKREEN 17 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 - 00850004812150 Catalog Number : 702001

Device Description : Kova Tox, DOA-SKREEN, Negative & Positive Urine Control 10mL Kitbox

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812167 Catalog Number : 19700000-10pk

Device Description : Negative Urine Control 10x5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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