FDA.reportPublic FDA data

HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT

Primary DI
00083059070330
Brand
HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT
Company
BIOMERICA, INC.
Model
7033
Device description
The hsCRP ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Published
2020-07-01
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003851000BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119Biocheck, Inc.2001-07-20DCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083059070330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083059070330000830590703300830590703300083059070330

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, kit, enzyme spectrophotometryA 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 an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
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
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08305900070330HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT70332016-12-07
08305900010015EZ Detect Fecal Occult Blood Test10012016-12-08
08305900100013EZ Detect Colon Disease Test1000-12016-12-08
00083059010015EZ Detect Fecal Occult Blood Test10012020-07-01
00083059100013EZ Detect Colon Disease Test1000-12020-07-01
08305901007151EZ-SALMONELLA One-Step Salmonella species Rapid Test1007-152016-12-08
00083059100754EZ-SALMONELLA One-Step Salmonella species Rapid Test1007-152020-07-01
08305900012033Aware Breast Self-Exam Pad12032016-12-07
08305900070040GAP®-IgG (Gastritis and Peptic Ulcer Test)70042016-12-08
08305900070231ACTH [Adrenocorticotropic Hormone] ELISA70232016-12-07
08305900070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]70242016-12-07
08305900070255EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]70252016-12-07
08305900070309Myoglobin Enzyme Immunoassay Test Kit70302016-12-07
08305900070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT70312016-12-08
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]70632016-12-08
08305900070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]70692016-12-08
08305900070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]70782016-12-08
08305901048253EZ-hCG Urine Pregnancy Test1048-252016-12-08
08305901501154EZ-GIARDIA One-Step Giardia Test1501-152016-12-08

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
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