CLINIQA CORPORATION

Address:495 Enterprise Street,San Marcos,CA,92078,US

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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) (1)

Premarket Exempt

No Yes

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Cardiac CalVer for Abbott Systems, Level A-E - 00817238010028 Catalog Number :

Device Description : LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abb LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abbott Systems, Level BLiniCAL Cardiac CalVer for Abbott Systems, Level CLiniCAL Cardiac CalVer for Abbott Systems, Level DLiniCAL Cardiac CalVer for Abbott Systems, Level E

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

LiquidQC CoV-2 IgG Control - 00817238010035 Catalog Number :

Device Description : CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays.

Device Class : 1

Duns Number: 078742335

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Cardiac Marker Control VS - 00817238010042 Catalog Number :

Device Description : Cardiac Marker Control VS Tri-Levels

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Liquid QC Cardiac Marker Control Complete Level 1 - 00817238010059 Catalog Number :

Device Description : Liquid QC Cardiac Marker Control +TnI Level 1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Cardiac Marker Complete Level 2 - 00817238010066 Catalog Number :

Device Description : Cardiac Marker Control +TnI Level 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

CARDIAC MARKER CONTROL LEVEL 3 - 00817238010073 Catalog Number :

Device Description : CARDIAC MARKER CONTROL +TnI Level 3

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

CARDIAC MARKER CONTROL TRI-LVL - 00817238010080 Catalog Number :

Device Description : CARDIAC MARKER CONTROL TRI-LEVEL

Device Class :

Duns Number: 078742335

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

CARDIAC MARKER CONTROL TRI-LVL - 00817238010097 Catalog Number :

Device Description : CARDIAC MARKER CONTROL TRI-LVL (min-pack)

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Tumor Marker Control level 3 - 00817238010103 Catalog Number :

Device Description : Tumor Marker Control level 3

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Tumor Marker Control level 1 - 00817238010110 Catalog Number :

Device Description : Tumor Marker Control level 1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

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