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

Salivabuse - 00810042680005 Catalog Number : 18100003

Device Description : Custom Oral Fluid, Negative, 500mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680012 Catalog Number : 19437908-6pk

Device Description : SERIES III 3X CUTOFF 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680029 Catalog Number : 19544908-6pk

Device Description : SERIES IV-H 3X Cutoff

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680036 Catalog Number : 19458908-6pk

Device Description : SERIES V 3X Cutoff, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680043 Catalog Number : 19447908-6pk

Device Description : SERIES IV 3X Cutoff, 6x20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Monicheck - 00810042680081 Catalog Number : AU-005

Device Description : AU-005, Multidrug Low OPI/MET, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Express Check - 00810042680142 Catalog Number : 18001129

Device Description : Express Check Negative, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : No

Device Count : 1

Detectabuse - 00810042680159 Catalog Number : 18001228

Device Description : STAT-SKREEN low COC/OPI/METH, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680166 Catalog Number : 18001229

Device Description : STAT-SKREEN lowCOC/OPI/METH,Cutoff +50%, 20 mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Express Check - 00810042680173 Catalog Number : 18001264

Device Description : Express Check Positive 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : No

Device Count : 1

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