UTAK LABORATORIES, INC.

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

URINE BROAD PANEL HIGH - B30001346000010 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU -25% GCMS - B80000357500010 Catalog Number :

Device Description : DAU -25% GCMS

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU +25% GCMS - B80000357500020 Catalog Number :

Device Description : DAU +25% GCMS

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

7-AMINO PLUS 100 NG/ML - B80000357500030 Catalog Number :

Device Description : 7-AMINO PLUS 100 NG/ML

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

BLANK WHOLE BLOOD - B80000625000010 Catalog Number :

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

BLANK WHOLE BLOOD - B80000925500010 Catalog Number :

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

URINE QC LOW - B80001390500010 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

URINE QC HIGH - B80001390500020 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

URINE QC LOW - B80001390500030 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

URINE QC HIGH - B80001390500040 Catalog Number :

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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