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 - 00810042680470 Catalog Number : 18003216

Device Description : Negative with Stabilizer, SG 1.03, 1L

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680487 Catalog Number : 18003217

Device Description : Synthetic Negative with Stabilizer, SG1.003, 1 L

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680494 Catalog Number : 18003276

Device Description : DOA, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680500 Catalog Number : 18003277

Device Description : DOA Cutoff +50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680517 Catalog Number : 18003278

Device Description : EUROFINS QC3, 25mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680548 Catalog Number : 18005143

Device Description : Negative 2x5ml pack

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680555 Catalog Number : 18005144

Device Description : SSHMOB,2X 2x5ml pack

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680562 Catalog Number : 18007525

Device Description : CP-UR Panel, Cutoff +50%, 50mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680579 Catalog Number : 18007530

Device Description : MDMA/6-MAM, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00810042680586 Catalog Number : 18007536

Device Description : Urine Alcohol kitbox, 2x4mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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