<?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>36abb310-278f-468b-b181-d4d752dfacd5</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-03-31</publicVersionDate><devicePublishDate>2016-09-24</devicePublishDate><deviceCommDistributionEndDate>2025-03-28</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M578GPALL1F2</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier><identifier><deviceId>M578GPALL1F0</deviceId><deviceIdType>Unit of Use</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Sensititre</brandName><versionModelNumber>GPALL1F</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>298203498</dunsNumber><companyName>TREK DIAGNOSTIC SYSTEMS LIMITED</companyName><deviceCount>10</deviceCount><deviceDescription xsi:nil="true"/><DMExempt>false</DMExempt><premarketExempt>false</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>false</rx><otc>false</otc><contacts><customerContact><phone>8006427029</phone><phoneExtension xsi:nil="true"/><email>info.Trek.US@thermofisher.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K073558</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>63869</gmdnCode><gmdnPTName>Multiple antibacterial susceptibility testing kit IVD</gmdnPTName><gmdnPTDefinition>A collection of reagents and other associated materials containing a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection), that may be impregnated on individual testing discs or in a strip format, intended to be used to determine the antibacterial susceptibility profile of a specific bacterial microorganism (excluding mycobateria), in a clinical specimen and/or culture isolate.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JWY</productCode><productCodeName>Manual Antimicrobial Susceptibility Test Systems</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>