<?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>78b6b777-673a-40b6-b73b-721514d88649</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-11-14</publicVersionDate><devicePublishDate>2022-11-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00664369200220</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>STROMATOLYSER-FB</brandName><versionModelNumber>FBA-200A</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>690664461</dunsNumber><companyName>SYSMEX CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>Lysing reagent for analysis of basophils and WBC
</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>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(888)879-7639</phone><phoneExtension xsi:nil="true"/><email>crc@sysmex.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>61165</gmdnCode><gmdnPTName>Blood cell lysis reagent IVD</gmdnPTName><gmdnPTDefinition>A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GGK</productCode><productCodeName>Products, Red-Cell Lysing Products</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Total Volume</sizeType><size unit="Liter" value="5"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="Degrees Celsius" value=""/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>