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) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Detectabuse - 00850004812174 Catalog Number : 19001066-10pk

Device Description : STAT-SKREEN with MDMA, OXY & BUP 2X CUTOFF POSITIVE, 10x5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812181 Catalog Number : 702017

Device Description : K2 Synthetic THC, JWH-018 5-PENTANOIC ACID URINE CONTROL KITBOX

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812198 Catalog Number : 19900100-2pk

Device Description : ETHYL GLUCURONIDE 1000 ng/mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812204 Catalog Number : 19582041-10pk

Device Description : CONFIRM 4, Cutoff -60%, 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812211 Catalog Number : 19330000-10pk

Device Description : GC/MS CUTOFF 10x50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812228 Catalog Number : 19572502-10pk

Device Description : GC/MS-H CUTOFF

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812235 Catalog Number : 702018

Device Description : NICOTINE CONTROLS (Cotinine 400ng/mL) 5mL KITBOX

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Pregnancy-Skreen - 00850004812242 Catalog Number : 702013

Device Description : Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Contr Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Control, 5mL Kitbox

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812259 Catalog Number : 19437252-6pk

Device Description : SERIES III CUTOFF -25% 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812266 Catalog Number : 19437756-6pk

Device Description : SERIES III 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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