FDA.reportPublic FDA data

CRP Control Set

Primary DI
00812137012159
Brand
CRP Control Set
Company
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model
L1 x 3 x 3mL, L2 x 3 x 3mL
Catalog number
502-155
Device description
These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation.
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00812137012159PrimaryGS10
00812137012425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812137012159008121370121598121370121590812137012159
00812137012425008121370124258121370124250812137012425

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of C-reactive protein (CRP) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004533328quality@cdsolinc.com

Regulatory Flags#

DUNS number
048144997
Device count
6
DM exempt
true
HCT/P
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812137011848Albumin Reagent500 mL501-3972016-10-12
00812137012005LDH Reagent SetR1 x 500mL, R2 x 125mL501-4132016-10-12
00812137011855Alkaline Phosphatase Reagent SetR1 x 500 mL, R2 x 125 mL501-3982016-10-12
00812137011886AST (SGOT) Reagent SetR1 x 500mL, R2 x 125mL501-4012016-10-12
00812137011961Creatinine Reagent SetR1 x 500mL, R2 x 125mL501-4092016-10-12
00812137012098CRP Reagent SetR1 x 50mL, R2 x 50mL501-4352016-10-12
00812137012142CRP Calibrator Set5 x 2mL502-1542016-10-12
00812137012197Multi-Analyte Lipid Control SetL1 x 3mL, L2 x 3mL, L3 x 3mL502-1602016-10-12
00812137012111Chemistry Calibrator Set10 x 5mL, 1 x 50mL502-1512016-10-12
00812137012128Chemistry Control Level I Set10 x 5mL502-1522016-10-12
00812137012135Chemistry Control Level II Set10 x 5mL502-1532016-10-12
00001812701208Triglycerides Reagent500mL501-4172016-10-12
00812137010254CDS-LTX CONTROL6 x 16 mL502-0062016-09-08
00812137010261CDS-LTX PRIMER6 x 16mL502-0072016-09-08
00812137011947Carbon Dioxide Reagent120mL501-4072016-10-12
00812137011916Urea Nitrogen Reagent SetR1 x 500mL, R2 x 125mL501-4042016-10-12
00081213701184Albumin Reagent500 mL501-3972016-10-12
00812137010216Boule Con-Diff Tri-Level6 x 4.5mL501-6052016-09-02
00812137010223Boule Cal1 x 3.0mL501-6062016-09-06
00812137010230Boule Con-Diff Tri-Level9 x 4.5mL501-6072016-09-06

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