CLINIQA CORPORATION

Address:495 Enterprise Street,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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1) Chromatography Separation/Zimmerman 17-Ketogenic Steroids (CDG) (1) Enzymatic Method, Ammonia (JIF) (1) Hexokinase, Glucose (CFR) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Assay, Glycosylated Hemoglobin (LCP) (1) Urease And Glutamic Dehydrogenase, Urea Nitrogen (CDQ) (1)

Premarket Exempt

No Yes

Clear

Hemoglobin A1c Calibrators - 00817238010783 Catalog Number :

Device Description : Hemoglobin A1c Calibrators

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Bun Rate Reagent - 00817238010820 Catalog Number :

Device Description : Bun Rate Reagent

Device Class : 2

Duns Number: 078742335

Premarket Exempt : No

Product Code : CDQ

Prescription Use : No

Device Count : 1

Fructosamine Calibrator - 00817238011032 Catalog Number :

Device Description : Fructosamine Calibrator

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

hsCRP Wide Range Reagent - 00817238011056 Catalog Number :

Device Description : hsCRP Wide Range Reagent

Device Class : 2

Duns Number: 078742335

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

Phosphorous Reagent - 00817238011117 Catalog Number :

Device Description : Phosphorous Reagent

Device Class :

Duns Number: 078742335

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Glucose UV REAGENT - 00817238011148 Catalog Number :

Device Description : Glucose UV REAGENT

Device Class : 2

Duns Number: 078742335

Premarket Exempt : No

Product Code : CFR

Prescription Use : No

Device Count : 1

BUN Reagent, Liquid - 00817238011193 Catalog Number :

Device Description : BUN Reagent, Liquid

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : CDG

Prescription Use : No

Device Count : 1

Ammonia Standard - 00817238011247 Catalog Number :

Device Description : Ammonia Standard

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JIF

Prescription Use : No

Device Count : 1

Protein 3 Calibration Verifier set for the BCI AU - 00817238011315 Catalog Number :

Device Description : Protein 3 Calibration Verifier set for the BCI AU

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Hemoglobin A1C Reagent - 00817238011322 Catalog Number :

Device Description : Hemoglobin A1C Reagent

Device Class : 2

Duns Number: 078742335

Premarket Exempt : No

Product Code : LCP

Prescription Use : No

Device Count : 1

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