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) (10)

Premarket Exempt

Yes

Clear

METALS LEVEL 1 - B80001696000010 Catalog Number :

Device Description : METALS LEVEL 1

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

METALS LEVEL 2 - B80001696000020 Catalog Number :

Device Description : METALS LEVEL 2

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

METALS LEVEL 1 - B80001696000030 Catalog Number :

Device Description : METALS LEVEL 1

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

METALS LEVEL 2 - B80001696000040 Catalog Number :

Device Description : METALS LEVEL 2

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

BUSULFAN LEVEL 1 - B80001696000070 Catalog Number :

Device Description : BUSULFAN LEVEL 1

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

BUSULFAN LEVEL 2 - B80001696000080 Catalog Number :

Device Description : BUSULFAN LEVEL 2

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

BUSULFAN LEVEL 3 - B80001696000090 Catalog Number :

Device Description : BUSULFAN LEVEL 3

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

GHB 20 MG/L - B80001978000020 Catalog Number :

Device Description : GHB 20 MG/L

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DRUGS OF ABUSE LEVEL 1 - B80002041000010 Catalog Number :

Device Description : DRUGS OF ABUSE LEVEL 1

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DRUGS OF ABUSE LEVEL 2 - B80002041000020 Catalog Number :

Device Description : DRUGS OF ABUSE LEVEL 2

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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