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 - 00850004812891 Catalog Number : 19470072

Device Description : STAT-SKREEN-H, Cutoff +25%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812907 Catalog Number : 19470073

Device Description : STAT-SKREEN-H, Cutoff -25% 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812914 Catalog Number : 19470075

Device Description : STAT-SKREEN-H, 3X Cutoff, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812921 Catalog Number : 19480100

Device Description : AU/NZ SKREEN, Cutoff -50%, 5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812938 Catalog Number : 19480200

Device Description : AU/NZ SKREEN, Cutoff +50%, 5mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812945 Catalog Number : 19481100

Device Description : AU/NZ SKREEN, Cutoff -50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812952 Catalog Number : 19482200

Device Description : AU/NZ SKREEN, Cutoff +50%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812969 Catalog Number : 18001419

Device Description : AU/NZ SKREEN, Cutoff -30%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812976 Catalog Number : 18001421

Device Description : AU/NZ SKREEN, Cutoff +25%, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Detectabuse - 00850004812983 Catalog Number : 18001422

Device Description : AU/NZ SKREEN, 3X Cutoff, 20mL

Device Class : 1

Duns Number: 028007698

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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