<?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>e33e5225-db9e-416a-ae75-558a129fbe80</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2021-09-08</publicVersionDate><devicePublishDate>2021-08-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00812101030516</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>ARK™ HS Benzodiazepine II Negative Calibrator</brandName><versionModelNumber>5073-0002-01</versionModelNumber><catalogNumber>5073-0002-01</catalogNumber><dunsNumber>164880598</dunsNumber><companyName>ARK DIAGNOSTICS INC</companyName><deviceCount>1</deviceCount><deviceDescription>ARK™ HS Benzodiazepine II Negative Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Assay.
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</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>5102706270</phone><phoneExtension xsi:nil="true"/><email>customersupport@ark-tdm.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>55526</gmdnCode><gmdnPTName>Benzodiazepine group IVD, calibrator</gmdnPTName><gmdnPTDefinition>A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DLJ</productCode><productCodeName>Calibrators, Drug Specific</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="8"/><storageHandlingLow unit="Degrees Celsius" value="2"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>