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) (6) Drug Mixture Control Materials (DIF) (2) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2)

Premarket Exempt

Yes

Clear

High Range Trace Elements - B800668150 Catalog Number : 66815

Device Description : HR Trace Elements

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Normal Range Trace Elements - B800668160 Catalog Number : 66816

Device Description : NR Trace Elements

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

High Range AED II - B800727400 Catalog Number : 72740

Device Description : HR AED II

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : No

Device Count : 1

Mid Range AED II - B800727410 Catalog Number : 72741

Device Description : MR AED II

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : No

Device Count : 1

MMA (Methylmalonic Acid) Level 1 - B800740530 Catalog Number : 74053

Device Description : MMA (Methylmalonic Acid) Level 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

MMA (Methylmalonic Acid) Level 2 - B800740540 Catalog Number : 74054

Device Description : MMA (Methylmalonic Acid) Level 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

SAMHSA Confirm Level 1 - B800818200 Catalog Number : 81820

Device Description : SAMHSA Confirm Level 1 (SMx OF)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

SAMHSA Confirm Level 2 - B800818210 Catalog Number : 81821

Device Description : SAMHSA Confirm Level 2 (SMx OF)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Volatiles (S) 2-Part - B800881190 Catalog Number : 88119

Device Description : Volatiles (S) 2-Part

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

UTAK Urine Drug Screen - B800881210 Catalog Number : 88121

Device Description : UTAK UDS (Urine Drug Screen)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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