FDA.reportPublic FDA data

ProciseDx Calibration Cartridge

Primary DI
08100322954295
Brand
ProciseDx Calibration Cartridge
Company
Chembio Diagnostic Systems Inc.
Model
5429
Device description
The ProciseDx Calibration Cartridge is an accessory with quantitative assigned values to the ProciseDx Analyzer and is used to confirm that the instrument is operating within specified limits. The calibration cartridge does not contact biological specimens and is not used for diagnostic testing. The intended users are clinical laboratory professionals responsible for completing a periodic calibration check of the ProciseDx Analyzer.
Published
2024-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DCKC-Reactive Protein, Antigen, Antiserum, And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DCKC-Reactive Protein, Antigen, Antiserum, And ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08100322954295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08100322954295081003229542958100322954295

GMDN Terms#

Term, Definition table
TermDefinition
Optical laboratory instrument performance standard calibrator/control IVD, reusableA solid phase or liquid reference standard of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160348470
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08100322953854Procise IFX53852024-08-16
08100322954301Procise ADL54302024-08-16
08100322943909ProciseDx Analyzer43902024-08-05
00607158000083DPP HIV-Syphilis65-9502-02020-12-29
00607158000113DPP Zika IgM Micro Reader70-1064-070-1064-02021-10-19
00607158000106DPP Zika IgM System65-9560-02020-08-06
00607158000007Chembio DPP HIV 1/2 Assay65-9500-02014-09-01
00607158000021Clearview Complete HIV 1/260-9523-02014-09-01
00607158000038Clearview HIV Reactive/Nonreactive Controls60-9546-02014-09-01
00607158000045Chembio DPP HIV 1/2 Rapid Test Control Pack60-9552-02014-09-01
00607158000052Chembio HIV 1/2 Stat-Pak Assay60-9505-12014-09-01
00607158000069Chembio SURE CHECK HIV 1/2 Assay60-9507-02016-06-01
00607158000076Chembio HIV Reactive/Nonreactive Controls60-9549-02014-09-01

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Primary DI, Brand, Company table
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08100322943909ProciseDx AnalyzerChembio Diagnostic Systems Inc.DCK2024-08-05
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10758750001965VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DCK2020-05-16
10758750006915VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DCK2020-05-16
10758750005062VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DCK2020-04-18
10758750005208VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DCK2020-04-18
00380740180331AlinityABBOTT LABORATORIESDCK2020-01-13
00850392007190BioCheck High Sensitive CRP EIA Test KitBIOCHECK, INC.DCK2019-10-08
00840239039545C-Reactive Protein HS ELISADRG International IncDCK2019-03-20
00817302022414Carolina Liquid Chemistries CRPhsWRCAROLINA LIQUID CHEMISTRIES CORPORATIONDCK2019-03-08
00817302022421Carolina Liquid Chemistries CRPhsWRCAROLINA LIQUID CHEMISTRIES CORPORATIONDCK2019-03-08
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00817302022445Carolina Liquid Chemistries CRPhsWRCAROLINA LIQUID CHEMISTRIES CORPORATIONDCK2019-03-08
00386100002244CRP Reagent KitMEDICA CORPORATIONDCK2019-02-14
00817238011056hsCRP Wide Range ReagentCLINIQA CORPORATIONDCK2018-08-23
00852169008171ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)CLEARCHEM DIAGNOSTICS INC.DCK2018-04-30
08058056681911CRP Ultra (MP)SENTINEL CH. SPADCK2018-02-27
00816426021259K-ASSAY® CRP (3) Calibrator DKAMIYA BIOMEDICAL COMPANY, LLCDCK2018-02-23
00630414596198Atellica CH CRP_2Siemens Healthcare Diagnostics Inc.DCK2017-12-27
08305900070330HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.DCK2016-12-07
00628055726029Pulse Scientific Inc.Pulse Scientific IncDCK2016-11-04
00812137012098CRP Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.DCK2016-10-12