FDA.reportPublic FDA data

Cardiac Calibration Verifiers for Beckman Systems

Primary DI
00817238011643
Brand
Cardiac Calibration Verifiers for Beckman Systems
Company
CLINIQA CORPORATION
Model
98232
Device description
Cardiac Calibration Verifiers for Beckman Systems
Published
2020-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080973000CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACCliniqa Corporation2008-06-02JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817238011643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817238011643008172380116438172380116430817238011643

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cardiac marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078742335
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817238010257LiquidQC NEPHROCHECK Control 839382024-06-05
00817238010332NEPHROCHECK Calibration Verification839392024-06-05
00817238010264NEPHROCHECK® Method Validation For VIDAS® 3839402019-01-29
00817238010271LIQUID QC LIPID CONTROL LEVEL 915012018-08-23
00817238010288LIQUID QC LIPID CONTROL LEVEL 2 915022018-08-23
00817238010295LIQUID QC LIPID CONTROL Bi-level 915052018-08-23
00817238011520LQC Cardiac Control CS, mini pack914492022-11-19
00817238011056hsCRP Wide Range Reagent855502018-08-23
00817238010103Tumor Marker Control level 3913032018-08-22
00817238010110Tumor Marker Control level 1 913012018-08-22
00817238010127Tumor Marker Control level 2913022018-08-22
00817238010134Tumor Marker Control Tri-level913042018-08-22
00817238010141ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3)911042018-08-22
00817238010158Tumor Marker Control Tri-level913092018-08-22
00817238010172ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3)911052018-08-22
00817238010189ImmuTROL Serum Protein Contrl Level 1911012018-08-22
00817238010196ImmuTROL Serum Protein Contrl Level 2911022018-08-22
00817238010202ImmuTROL Serum Protein Contrl Level 3911032018-08-22
00817238010219hsCRP Serum Protein Control Level 1912012018-08-22
00817238010226hsCRP Serum Protein Control Level 2912022018-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135716ValidateLgc Clinical Diagnostics, Inc.JJY2024-09-05
00852676007087Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007094Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007100Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
03610522248377LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248384LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248391LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248407LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248667LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248674LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248681LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31