<?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>4f73293b-38d7-400a-b06b-19fd2316385b</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-08-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08426950594635</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>QUANTA Lite® ACA IgG III ELISA Bulk Pack</brandName><versionModelNumber>708625.10</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>188354831</dunsNumber><companyName>INOVA DIAGNOSTICS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder
2. 5x 1.2mL prediluted ACA Negative Control 
3. 5x 1.2mL prediluted ACA IgG III Control
4. 5x 1.2mL prediluted ACA IgG III Calibrator A
5. 5x 1.2mL prediluted ACA IgG III Calibrator B
6. 5x 1.2mL prediluted ACA IgG III Calibrator C
7. 5x 1.2mL prediluted ACA IgG III Calibrator D
8. 5x 1.2mL prediluted ACA IgG III Calibrator E
9. 9x 50mL ACA III Sample Diluent
10. 10x 50mL ACA III PBS Concentrate, 20x concentrate
11. 10x 10mL ACA IgG III Conjugate, (goat), anti-human IgG
12. 10x 10mL TMB Chromogen
13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
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