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

DAU IA 3 - B800506020 Catalog Number : 50602

Device Description : DAU IA 3

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU IA 4 - B800506030 Catalog Number : 50603

Device Description : DAU IA 4

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU IA 5 - B800506040 Catalog Number : 50604

Device Description : DAU IA 5

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU HC 1 - B800507000 Catalog Number : 50700

Device Description : DAU HC 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU HC 2 - B800507010 Catalog Number : 50701

Device Description : DAU HC 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU LC 1 - B800507020 Catalog Number : 50702

Device Description : DAU LC 1

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

DAU LC 2 - B800507030 Catalog Number : 50703

Device Description : DAU LC 2

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Steroids Level 1 (SMx Serum) - B800514010 Catalog Number : 51401

Device Description : Steroids Level 1 (SMx Serum)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Steroids Level 2 (SMx Serum) - B800514020 Catalog Number : 51402

Device Description : Steroids Level 2 (SMx Serum)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Steroids Level 3 (SMx Serum) - B800514030 Catalog Number : 51403

Device Description : Steroids Level 3 (SMx Serum)

Device Class : 1

Duns Number: 092519016

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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