Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

CLINIQA CORPORATION

United States·US-MF-000023908

Last updated September 17, 2026

Information

Country
United States
Address
495, Enterprise Street, San Marcos, United States
LinkedIn
—
Facebook
—
Phone
1-800-728-5205
PRRC Contact
Stephanie Mantooth
EUDAMED SRN
US-MF-000023908
FDA FEI Number
1000135102
DUNS Number
—

Catalogue (112)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
Immunoassay Control Level 1 94101
FDA UDI
Class IActive
NEPHROCHECK Calibration Verification 83939
FDA UDI
Class IActive
Cardiac CalVer for Abbott Systems, Level A-E 98602
FDA UDI
Class IUnknown
Ammonia Standard R85406
FDA UDI
Class IActive
Whole Blood Ethanol Control Level 2 93212
FDA UDI
Class IActive
Protein 3 Calibration verifier Set for the Roche Integra 98503
FDA UDI
Class IActive
Cardiac Marker Control Tri-Lvl 91484
FDA UDI
N/AActive
DropStrip Urinalysis Control Bi-Level 97202
FDA UDI
Class IActive
Whole Blood Ethanol Control Level1 93211
FDA UDI
Class IActive
Cardiac Control Complete +TnT level 3 91492
FDA UDI
Class IActive
Assay Control Serum Level 2 R83083
FDA UDI
Class IActive
ImmuTROL Serum Protein Contrl Level 1 91101
FDA UDI
N/AActive
Liquid QC Immunoassay Control Tri-Level 94104
FDA UDI
Class IActive
ImmuTROL Serum Protein Contrl Level 2 91102
FDA UDI
Class IActive
DipStrip Urinalysis Control Bi-Level 97201
FDA UDI
Class IActive
Cardiac Calibration Verifiers for Roche Systems 98505
FDA UDI
Class IActive
Immunoassay Control Level 2 94102
FDA UDI
Class IActive
Protein 3 Calibration Verifier set for the BCI AU 98303
FDA UDI
Class IActive
hsCRP Serum Protein Control Level 1 91201
FDA UDI
Class IActive
BUN Rate Reagent R82042
FDA UDI
Class IActive
LiquidQC NEPHROCHECK Control 83938
FDA UDI
N/AActive
DIABETES CNTL, Bi-L 91815
FDA UDI
Class IActive
Lipid Calibrator, Lyophilized R85528
FDA UDI
N/AActive
hsCRP Serum Protein Control Level 2 91202
FDA UDI
N/AActive
Cardiac Control Complete +TnT level 1 91490
FDA UDI
Class IActive
Linical Protein 2 Calibration Verifiers Levels A-E For Olympus Au Analyzers K031575
FDA 510(k)
Class IActive
Linical Protein 2 Calibration Verifiers Levels A-E For The Beckman-Coulter Immage K023250
FDA 510(k)
Class IActive
Linical Hscrp Calibration Verifiers Levels A-E For The Dade Bn Ii Nephelometer K022758
FDA 510(k)
Class IActive
Cliniqa Liquid Qc Unassayed And Assayed General Chemistry Control Levels 1, 2, & 3 K070741
FDA 510(k)
Class IActive
Cliniqa Liquid-Qc Hcg Control Level 1, 2, And 3 K022232
FDA 510(k)
Class IActive
Linical Rf-Crp Calibration Verifiers Levels A-E For Beckman Coulter Synchron Cx Systems K023661
FDA 510(k)
Class IActive
Cliniqa Liquid Qc Urinalysis Controls, Levels 1 And 2 K081908
FDA 510(k)
Class IActive
Cliniqa Liquid Qc Cardiac Marker Control Sp, Levels 1, 2, &3 K062916
FDA 510(k)
Class IActive
Cliniqa Liquid Qc Cardiac Marker Control Levels 1, 2 & 3, Tri-Level K030768
FDA 510(k)
Class IActive
Linical Chemistry Calibration Verifiers Levels A - E For Beckman Coulter Synchron Systems K031921
FDA 510(k)
Class IActive
Olympus Urine Calibrator K033910
FDA 510(k)
Class IIActive
Linical Enzyme Calibration Verifiers Levels A-E For Beckman Coulter Synchron Systems K040535
FDA 510(k)
Class IActive
Linical Protein 5 Calibration Verifiers Levels A-E For Beckman Coulter Array And Immage Protein Systems K030150
FDA 510(k)
Class IActive
Cliniqa Liquid Qc Tumor Marker Control Level 1, Level 2, Level 3, And Tri Level K030705
FDA 510(k)
Class IActive
Linical Uric Acid Calibration Verifiers Levels A - E For Olympus Au Systems K040455
FDA 510(k)
Class IActive
Cliniqa Liquid Qc Bilirubin Controls Levels 1, 2 & 3; Cliniqa Linical Bilirubin Calibration Verifiers Levels A-E K052679
FDA 510(k)
Class IActive
Linical Hscrp Calibration Verifiers Levels A-E For Beckman Coulter Immage K022936
FDA 510(k)
Class IActive
Linical Esoterics Calibration Verifiers Levels A-E For Beckman Coulter Synchron Analyzers K032074
FDA 510(k)
Class IActive
Cliniqa Dry Qc Chemistry Control, Levels 1 And 2, Assayed, Cliniqa Dry Qc Chemistry Control, Level 1 And 2 Unassayed K060322
FDA 510(k)
Class IIActive
Cliniqa Liquid Qc Complete Cardiac Marker Control, Levels 1, 2, And 3; Cardiac Marker Control-Low, And Linical Cardiac K080973
FDA 510(k)
Class IActive
Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3 K083554
FDA 510(k)
Class IActive
Linical Protein I Calibration Verifiers Levels A=e For Beckman Coulter Immage K013332
FDA 510(k)
Class IActive
Linical Protein 3 Calibration Verifiers Levels A-E For The Olympus Au Series Chemistry Immuno Analyzers K030566
FDA 510(k)
Class IActive
Linical Hscrp Calibration Verifiers Levels A-E For Olympus Au Systems K022491
FDA 510(k)
Class IActive
Linical Esoterics Calibration Verifiers Levels A-E For Olympus Au Systems K040091
FDA 510(k)
Class IActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.