CLINIQA CORPORATION

Address:258 la Moree Rd,San Marcos,CA,92078,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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (5) Alcohol Control Materials (DKC) (2) Chromatography Separation/Zimmerman 17-Ketogenic Steroids (CDG) (1) Enzymatic Method, Ammonia (JIF) (1)

Premarket Exempt

No Yes

Clear

BUN Rate Reagent - 00817238011391 Catalog Number :

Device Description : BUN Rate Reagent

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : CDG

Prescription Use : No

Device Count : 1

Ammonia Reagent - 00817238011438 Catalog Number :

Device Description : Ammonia Reagent

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JIF

Prescription Use : No

Device Count : 1

LQC Cardiac Control CS, Tri-level kit - 00817238011513 Catalog Number :

Device Description : LQC Cardiac Control CS, Tri-level kit

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Vitamin D - 00817238011551 Catalog Number :

Device Description : Vitamin D

Device Class :

Duns Number: 078742335

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

WHOLE BLOOD ETHANOL CONTROL LEVEL1 - 00817238011568 Catalog Number :

Device Description : WHOLE BLOOD ETHANOL CONTROL LEVEL1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : DKC

Prescription Use : No

Device Count : 1

WHOLE BLOOD ETHANOL CONTROL LEVEL 2 - 00817238011575 Catalog Number :

Device Description : WHOLE BLOOD ETHANOL CONTROL LEVEL 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : DKC

Prescription Use : No

Device Count : 1

WHOLE BLD VOLATILES CONTROL LEVEL 1 - 00817238011582 Catalog Number :

Device Description : WHOLE BLD VOLATILES CONTROL LEVEL 1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

WHOLE BLOOD VOLATILES CONTTROL LEVEL 2 - 00817238011599 Catalog Number :

Device Description : WHOLE BLOOD VOLATILES CONTTROL LEVEL 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Cardiac Control Complete +TnT level 1 - 00817238011605 Catalog Number :

Device Description : Cardiac Control Complete +TnT level 1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Cardiac Control Complete +TnT level 2 - 00817238011612 Catalog Number :

Device Description : Cardiac Control Complete +TnT level 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

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