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

VLGR LEVEL 3 - B80002509000070 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

PM PANEL COMBO V9 - B80002942500010 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

P/Z CALIBRATOR - B80002942500020 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

PSYCH URINE V3 CALIBRATOR - B80002942500030 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

P/Z CALIBRATOR V2 - B80002942500040 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

P/Z QC LOW - B80002942500050 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

P/Z QC HIGH - B80002942500060 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DRUGS OF ABUSE CALIBRATOR V6 - B80002942500070 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

OF QC 4 - B80002942500080 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

OF QC 3 - B80002942500090 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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