ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.

Recall details

Manufacturer

Radiometer Medical ApS

Distributor

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Dominican Republic, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Iran, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe Australia, New Zealand, New Caledonia, Tokelau, Austria, Belgium, Netherlands, China, Croatia, Czech Republic, Slovakia, Denmark, Iceland, Finland, Estonia, France, Germany, Hong Kong, Hungary, India, Brunei, Italy, Japan, Kazakhstan, Malaysia, Mexico, Norway, Poland, Russia, Singapore, South Africa, Cameroon, Ivory Coast, Malawi, South Korea, Spain, Portugal, Sweden, Switzerland, Turkey, United Kingdom, Ireland.

Lot

Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825 754R0241N010 754R0241N010 ABL825 754R0334N006 754R0334N006 ABL825 754R0417N008 754R0417N008 ABL825 754R0449N004 754R0449N004 ABL825 754R0487N004 754R0487N004 ABL837 754R0631N006 754R0631N006 ABL825 754R0755N003 754R0755N003 ABL825 754R0757N007 754R0757N007 ABL825 754R0884N007 754R0884N007 ABL825 754R0917N002 754R0917N002 ABL825 754R0918N007 754R0918N007 ABL810 754R0941N008 754R0941N008 ABL827 754R1001N004 (01)05700693938004(10)754R1001N004 ABL805 754R1028N005 754R1028N005 ABL825 754R1105N005 754R1105N005 ABL825 754R1157N006 754R1157N006 ABL825 754R1204N006 754R1204N006 ABL805 754R1209N005 754R1209N005 ABL825 754R1220N003 754R1220N003 ABL805 754R1222N005 754R1222N005 ABL805 754R1222N006 754R1222N006 ABL825 754R1222N009 754R1222N009 ABL825 754R1223N008 754R1223N008 ABL805 754R1226N007 754R1226N007 ABL825 754R1234N003 754R1234N003 ABL825 754R1238N009 754R1238N009 ABL825 754R1238N011 754R1238N011 ABL825 754R1239N007 754R1239N007 ABL825 754R1239N009 754R1239N009 ABL825 754R1239N010 754R1239N010 ABL820 754R1240N011 754R1240N011 ABL825 754R1261N006 754R1261N006 ABL825 754R1262N007 754R1262N007 ABL825 754R1266N006 754R1266N006 ABL825 754R1267N003 754R1267N003 ABL805 754R1291N003 754R1291N003 ABL835 754R1371N011 754R1371N011 ABL835 754R1377N002 754R1377N002 ABL827 754R1404N002 (01)05700693938004(10)754R1404N002 ABL825 754R1427N003 754R1427N003 ABL805 754R1427N007 754R1427N007 ABL805 754R1427N008 754R1427N008 ABL825 754R1428N001 754R1428N001 ABL825 754R1462N005 (01)05700693938004(10)754R1462N005 ABL825 754R1466N007 (01)05700693938004(10)754R1466N007 ABL837 754R1469N002 (01)05700693938004(10)754R1469N002 ABL825 754R1494N004 (01)05700693938004(10)754R1494N004 ABL805 754R1644N003 (01)05700693938004(10)754R1644N003 ABL825 754R1664N005 (01)05700693938004(10)754R1664N005 ABL825 754R1664N007 (01)05700693938004(10)754R1664N007 ABL827 754R1669N006 (01)05700693938004(10)754R1669N006 ABL825 754R1700N004 (01)05700693938004(10)754R1700N004 ABL805 754R1706N001 (01)05700693938004(10)754R1706N001 ABL835 754R1733N006 (01)05700693938004(10)754R1733N006 ABL820 754R1739N003 (01)05700693938004(10)754R1739N003 ABL805 754R1759N002 (01)05700693938004(10)754R1759N002 ABL837 754R1777N005 (01)05700693938004(10)754R1777N005 ABL837 754R1798N002 (01)05700693938004(10)754R1798N002 ABL820 754R1813N008 (01)05700693938004(10)754R1813N008 ABL825 754R1814N005 (01)05700693938004(10)754R1814N005 ABL825 754R1818N005 (01)05700693938004(10)754R1818N005 ABL820 754R1864N001 (01)05700693938004(10)754R1864N001 ABL820 754R1864N002 (01)05700693938004(10)754R1864N002 ABL820 754R1870N004 (01)05700693938004(10)754R1870N004 ABL825 754R1886N008 (01)05700693938004(10)754R1886N008 ABL837 754R1886N009 (01)05700693938004(10)754R1886N009 ABL827 754R1887N002 (01)05700693938004(10)754R1887N002 ABL827 754R1887N003 (01)05700693938004(10)754R1887N003 ABL837 754R1887N005 (01)05700693938004(10)754R1887N005 ABL827 754R1887N006 (01)05700693938004(10)754R1887N006 ABL820 754R1887N007 (01)05700693938004(10)754R1887N007 ABL825 754R1887N008 (01)05700693938004(10)754R1887N008 ABL825 754R1887N009 (01)05700693938004(10)754R1887N009 ABL825 754R1896N001 (01)05700693938004(10)754R1896N001 ABL817 754R1920N003 (01)05700693938004(10)754R1920N003 ABL825 754R1924N005 (01)05700693938004(10)754R1924N005 ABL835 754R1929N007 (01)05700693938004(10)754R1929N007 ABL825 754R1954N002 (01)05700693938004(10)754R1954N002 ABL835 754R1965N002 (01)05700693938004(10)754R1965N002 ABL835 754R1965N005 (01)05700693938004(10)754R1965N005 ABL835 754R1965N007 (01)05700693938004(10)754R1965N007 ABL837 754R1968N003 (01)05700693938004(10)754R1968N003 ABL805 754R1969N004 (01)05700693938004(10)754R1969N004 ABL825 754R1985N004 (01)05700693938004(10)754R1985N004 ABL835 754R1988N003 (01)05700693938004(10)754R1988N003 ABL835 754R1988N005 (01)05700693938004(10)754R1988N005 ABL825 754R2009N003 (01)05700693938004(10)754R2009N003 ABL82

Risk classification

Class II

Area (FDA)

device

Country

Denmark