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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (8) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2)

Premarket Exempt

No Yes

Clear

hsCRP Serum Protein Control Level 3 - 00817238010233 Catalog Number :

Device Description : hsCRP Serum Protein Control Level 3

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

hsCRP Serum Protein Control Tri-Level - 00817238010240 Catalog Number :

Device Description : hsCRP Serum Protein Control Tri-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Liquid QC Cardiac Marker Control (NT-proBNP/D-Dimer) - 00817238010264 Catalog Number :

Device Description : Liquid QC Cardiac Marker Control (NT-proBNP/D-Dimer)

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

LIQUID QC LIPID CONTROL LEVEL - 00817238010271 Catalog Number :

Device Description : LIQUID QC LIPID CONTROL LEVEL

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

LIQUID QC LIPID CONTROL LEVEL 2 - 00817238010288 Catalog Number :

Device Description : LIQUID QC LIPID CONTROL LEVEL 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

LIQUID QC LIPID CONTROL Bi-level - 00817238010295 Catalog Number :

Device Description : LIQUID QC LIPID CONTROL Bi-level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Urine Chemistry Control Bi-Level - 00817238010318 Catalog Number :

Device Description : Urine Chemistry Control Bi-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Urine Chemistry Control Bi-Level - 00817238010325 Catalog Number :

Device Description : Urine Chemistry Control Bi-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

DIABETES CNTL, Bi-L - 00817238010387 Catalog Number :

Device Description : DIABETES CONTROL BI-LEVEL

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

DIABETES CNTL, Smpl, 1x2x0.5mL - 00817238010394 Catalog Number :

Device Description : DIABETES CONTROL SAMPLE PACK

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

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