UTAK LABORATORIES, INC.

Address:25020 AVENUE TIBBITTS,VALENCIA,CA,91355,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 Specific Control Materials (LAS) (9) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1)

Premarket Exempt

Yes

Clear

Z Drugs Plus Level 2 - B800415010 Catalog Number : 41501

Device Description : Z Drugs Plus Level 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Immunosuppressants Level 1 - B800416300 Catalog Number : 41630

Device Description : Immunosuppressants Level 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Immunosuppressants Level 2 - B800416310 Catalog Number : 41631

Device Description : Immunosuppressants Level 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Immunosuppressants Level 3 - B800416320 Catalog Number : 41632

Device Description : Immunosuppressants Level 3

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Antifungals Level 1 - B800430100 Catalog Number : 43010

Device Description : Antifungals Level 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Antifungals Level 2 - B800430110 Catalog Number : 43011

Device Description : Antifungals Level 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Drugs of Abuse 505 Cutoff Oral Fluid - B800430500 Catalog Number : 43050

Device Description : DOA 50% Cutoff

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DOA Cutoff (OF) Frozen - B800430510 Catalog Number : 43051

Device Description : DOA Cutoff (OF) Frozen

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DOA 200% Cutoff Oral Fluid - B800430520 Catalog Number : 43052

Device Description : DOA Cutoff (OF)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

STABBS Positive - B800445100 Catalog Number : 44510

Device Description : STABBS Positive

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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