<?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>ba9f2526-d584-4d07-8314-b6835b93093e</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-09-02</publicVersionDate><devicePublishDate>2024-08-23</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00673693089340</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>Epredia</brandName><versionModelNumber>Congo Red Solution</versionModelNumber><catalogNumber>88005</catalogNumber><dunsNumber>929504710</dunsNumber><companyName>RICHARD-ALLAN SCIENTIFIC COMPANY</companyName><deviceCount>1</deviceCount><deviceDescription>The Amyloid Stain kit is a special stain technique to identify amyloid in tissue sections. Amyloid, a fiber-like protein, can be stained with Congo Red solution. Sodium Hydroxide is added to the solution to break down hydrogen bonds between adjacent amyloid fibers allowing more bonding sites for the Congo Red. A light counterstain with Mayer’s hematoxylin allows contrast. Amyloid can be best detected by the use of green birefringence under a polarized lens of a light microscope. Care should be taken to section tissue sections at a thickness of 7-10 microns for optimal staining.</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/><gmdnTerms><gmdn><gmdnCode>43587</gmdnCode><gmdnPTName>Biological stain IVD</gmdnPTName><gmdnPTDefinition>A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ICH</productCode><productCodeName>Congo Red</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>