FDA.reportPublic FDA data

Teco Diagnostics C-Reactive Protein (CRP) Reagent Set

Primary DI
10673486002430
Brand
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set
Company
TECO DIAGNOSTICS
Model
CRP-100
Catalog number
CRP-100
Device description
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum.
Published
2024-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K962019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962019000C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TESTTeco Diagnostics1996-11-25DCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486002430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600243010673486002430

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, kit, rapid agglutination, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of C-reactive protein (CRP) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. CRP is a marker associated with bacterial infection and inflammatory conditions. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

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
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
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10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MATRIX-160TC-MATRIX-1602025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-240TC-Matrix-2402025-05-28
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10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestP596-25P596-252024-12-19

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
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
00812137012098CRP Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.DCK2016-10-12