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) (9) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1)

Premarket Exempt

Yes

Clear

STABBS Negative - B800445110 Catalog Number : 44511

Device Description : STABBS Negative

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Metals Level 1 - B800445210 Catalog Number : 44521

Device Description : Metals Level 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Metals Level 2 - B800445220 Catalog Number : 44522

Device Description : Metals Level 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Metals Level 3 - B800445230 Catalog Number : 44523

Device Description : Metals Level 3

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Blank Serum - B800446000 Catalog Number : 44600

Device Description : Blank Serum

Device Class :

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Defibrinated Plasma - B8004460010 Catalog Number : 44600-D(500)

Device Description : Defibrinated Plasma (Frozen)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Normal Human Serum - B8004460020 Catalog Number : 44600-S(500)

Device Description : Normal Human Serum (Frozen)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Blank Whole Blood - B8004460030 Catalog Number : 44600-WB(F)

Device Description : Blank Whole Blood (Frozen)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU IA 1 - B800506000 Catalog Number : 50600

Device Description : DAU IA 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU IA 2 - B800506010 Catalog Number : 50601

Device Description : DAU IA 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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