FDA.reportPublic FDA data

Mix-Rate® X20 Automated ESR Analyzer

Primary DI
03661540300042
Brand
Mix-Rate® X20 Automated ESR Analyzer
Company
ELITECHGROUP INC.
Model
PRD-X20-EL-08TKNE
Catalog number
PRD-X20-EL-08TKNE
Device description
The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.
Published
2023-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKBDevice, Automated Sedimentation Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKBDevice, Automated Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540300042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540300042036615403000423661540300042

GMDN Terms#

Term, Definition table
TermDefinition
Erthrocyte sedimentation rate (ESR) analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 453 2725service.ebs@elitechgroup.com

Regulatory Flags#

DUNS number
052423787
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540300400Macroduct Advanced Sweat Collection SystemModel 3710-Sys2025-02-27
03661540304156Potassium Electrode279-001279-0012023-10-01
03661540304163Chloride Electrode280-001280-0012023-10-01
03661540304170Carbon Dioxide Electrode275-001275-0012023-10-01
03661540304187Sodium Electrode278-001278-0012023-10-01
03661540300288Monosed® ESR Vacuum Tubes, CartonPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonEX-50100EX-501002023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonEX-50205EX-502052023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonEP-10605EP-106052023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonEP-10605-H1EP-10605-H12023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerPRD-MSS-EL-08TKNEPRD-MSS-EL-08TKNE2023-10-01
03661540300202Monosed® ESR Vacuum TubesPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesEX-50100EX-501002023-10-01
03661540300257Excyte® ESR Vacuum TubesEX-50205EX-502052023-10-01
03661540300264Excyte® ESR Vacuum TubeEP-10605EP-106052023-10-01
03661540300271Excyte® ESR Vacuum TubeEP-10605-H1EP-10605-H12023-10-01
03661540304286Direct A1c Control Kit55136551362023-10-01
03661540304293Direct A1c Calibrator Kit55120551202023-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719189137781StarrsedMechatronics USA LLCGKB2024-08-26
00860011967736ZBT-ESRSTERILE SAFEQUIP & CHEMICALS LLPGKB2024-07-09
00868556000208ESR STAT 6Airscan, Inc.GKB2024-06-04
08033891324551VES-MATIC ORIGINALDIESSE DIAGNOSTICA SENESE SPAGKB2023-12-14
00850028040041iSED EliteALCOR SCIENTIFIC INC.GKB2023-11-03
03661540300288Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300202Monosed® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300257Excyte® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300264Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
03661540300271Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
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08719189137125Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137149Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137170Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137286StarrsedMechatronics USA LLCGKB2022-12-05
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