Mix-Rate® X20 Automated ESR Analyzer PRD-X20-EL-08TKNE

GUDID 03661540300042

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.

ELITECHGROUP INC.

Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD
Primary Device ID03661540300042
NIH Device Record Keye37d1130-98d7-45ff-93f8-329a4bf37f03
Commercial Distribution StatusIn Commercial Distribution
Brand NameMix-Rate® X20 Automated ESR Analyzer
Version Model NumberPRD-X20-EL-08TKNE
Catalog NumberPRD-X20-EL-08TKNE
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540300042 [Primary]

FDA Product Code

GKBDevice, Automated Sedimentation Rate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-09
Device Publish Date2023-10-01

Devices Manufactured by ELITECHGROUP INC.

03661540300035 - Microsed-System® Automated ESR Analyzer2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de
03661540300042 - Mix-Rate® X20 Automated ESR Analyzer2023-10-09The 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.
03661540300042 - Mix-Rate® X20 Automated ESR Analyzer2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de
03661540300202 - Monosed® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300219 - Monosed® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300240 - Excyte® ESR Non-Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300257 - Excyte® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300264 - Excyte® ESR Vacuum Tube, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300271 - Excyte® ESR Vacuum Tube, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy

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