<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>a7a853ce-19c7-46ae-aaf2-47a6babffdb9</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2021-03-01</publicVersionDate><devicePublishDate>2021-02-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03661540304149</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Accu-Sed® Plus Norm &amp; Abn ESR Control Kit, 2x8.5mL</brandName><versionModelNumber>DS-71004</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>052423787</dunsNumber><companyName>ELITECHGROUP INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration. 
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>1-800-453-2725</phone><phoneExtension xsi:nil="true"/><email>service_ebs@elitechgoup.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>55972</gmdnCode><gmdnPTName>Erythrocyte sedimentation rate (ESR) IVD, control</gmdnPTName><gmdnPTDefinition>A material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JJX</productCode><productCodeName>Single (Specified) Analyte Controls (Assayed And Unassayed)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="Degrees Celsius" value="18"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>