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) (7) Urinalysis Controls (Assayed And Unassayed) (JJW) (2)

Premarket Exempt

No Yes

Clear

MicroStrip Urinalysis Control Bi-Level - 00817238010509 Catalog Number :

Device Description : MicroStrip Urinalysis Control Bi-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

DipScopics Urinalysis Control Bi-Level - 00817238010516 Catalog Number :

Device Description : DipScopics Urinalysis Control Bi-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

LIPID CALIBRATOR, LYOPHILIZED - 00817238010523 Catalog Number :

Device Description : LIPID CALIBRATOR, LYOPHILIZED

Device Class :

Duns Number: 078742335

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Assay Control Serum Level 1 - 00817238010578 Catalog Number :

Device Description : Assay Control Serum Level 1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Assay Control Serum Level 2 - 00817238010585 Catalog Number :

Device Description : Assay Control Serum Level 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F - 00817238010660 Catalog Number :

Device Description : LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Protein 2 Calibration Verifier Set for the Roche Integra - 00817238010677 Catalog Number :

Device Description : Protein 2 Calibration Verifier Set for the Roche Integra

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Protein 3 Calibration verifier Set for the Roche Integra - 00817238010684 Catalog Number :

Device Description : Protein 3 Calibration verifier Set for the Roche Integra

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Protein 4 Calibration verifier Set for the Roche Integra - 00817238010691 Catalog Number :

Device Description : Protein 4 Calibration verifier Set for the Roche Integra

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Protein 2 Calibration Verifier set for the BCI AU - 00817238010745 Catalog Number :

Device Description : Protein 2 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

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