FDA.reportPublic FDA data

CRP Titer Control

Primary DI
08426950590460
Brand
CRP Titer Control
Company
BIOKIT, S.A.
Model
300021061
Device description
2 x 1 ml titrated control
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904312000RHEUMAGEN CRP T-CONTROLBiokit USA, Inc.1990-10-01DCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950590460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950590460084269505904608426950590460

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 qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].

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
1-800-926-3353support@inovadx.com

Regulatory Flags#

DUNS number
460055742
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
08426950639725BIO-FLASH3710-03442016-09-23
08426950344773Color Mono 50 TESTS3000-10052016-09-23
08426950590453ASO Titer Control3000210602016-09-23
08426950590477RF Titer Control3000210622016-09-23
08426950590569Rubagen 100 TESTS3000240012016-09-23
08426950590576Rubajet 100 TESTS3000240112016-09-23
08426950590583Rubajet 500 TESTS3000240122016-09-23
08426950589365Rheumajet CRP 100 TESTS3000-70512016-09-23
08426951056439biokitHSV-23000280012022-10-10
08426950001676Monogen 50 TESTS3000-10012016-09-23
08426950585350Monogen 150 TESTS3000-10022016-09-23
08426950589334Rheumajet RF 100 TESTS3000-70332016-09-23
08426950590613Rheumajet RF 50 TESTS3000270342016-09-23
08426950592327Biokit RPR 500 TESTS3006255502016-09-23
08426950457305Rheumajet ASO 100 TESTS3000-70102016-09-23

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