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 Mixture Control Materials (DIF) (3) Drug Specific Control Materials (LAS) (3)

Premarket Exempt

Yes

Clear

Lead Level 1 - B800933110 Catalog Number : 93311

Device Description : Lead Level 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : No

Device Count : 1

Lead Level 2 - B800933120 Catalog Number : 93312

Device Description : Lead Level 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : No

Device Count : 1

Lead Level 3 - B800933130 Catalog Number : 93313

Device Description : Lead Level 3

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : No

Device Count : 1

Drugs of Abuse Level 1 - B800988180 Catalog Number : 98818

Device Description : Drugs of Abuse Level 1 (WB)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Drugs of Abuse Level 2 - B800988190 Catalog Number : 98819

Device Description : Drugs of Abuse Level 2 (WB)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Volatiles (WB) 2-Part - B800991190 Catalog Number : 99119

Device Description : Volatiles (WB) 2-Part

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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