FDA.reportPublic FDA data

Wide Range CRP Assay

Primary DI
00628063400430
Brand
Wide Range CRP Assay
Company
SEKISUI DIAGNOSTICS, LLC
Model
250-20
Catalog number
250-20
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060139000CRP-ADVANCE ASSAY, MODELS 250-20, 250-25Diagnostic Chemicals , Ltd.2006-04-28DCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400430006280634004306280634004300628063400430

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
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
00742860100413Acucy Printer Paper10192026-02-27
10742860100410Acucy Printer Paper10192026-02-27
00742860100444Acucy Reader A/C Adapter10432026-02-27
00742860100475Acucy System Universal Drawer10512026-02-27
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816426021549K-ASSAY® CRP Reagent (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCDCK2026-02-27
00816426021556K-ASSAY® CRP Calibrator (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCDCK2026-02-27
08100322954295ProciseDx Calibration CartridgeChembio Diagnostic Systems Inc.DCK2024-08-06
08100322943909ProciseDx AnalyzerChembio Diagnostic Systems Inc.DCK2024-08-05
10673486002430Teco Diagnostics C-Reactive Protein (CRP) Reagent SetTECO DIAGNOSTICSDCK2024-04-02
04048474039542C-Reactive Protein HS ELISADRG Instruments Gesellschaft mit beschränkter HaftungDCK2023-08-31
00811727015815Pointe CRP ReagentHORIBA INSTRUMENTS INCORPORATEDDCK2021-01-30
00811727016126Pointe CRP ReagentHORIBA INSTRUMENTS INCORPORATEDDCK2021-01-30
03610230007297Yumizen C1200 CRP HORIBA ABX SASDCK2020-07-13
00083059070330HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.DCK2020-07-01
10758750001637VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DCK2020-05-16
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
00817302022438Carolina Liquid Chemistries CRPhsWRCAROLINA LIQUID CHEMISTRIES CORPORATIONDCK2019-03-08
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