The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the 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) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the 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) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.

Detalles del retiro

Fabricante

Radiometer America Inc

Distribuidor

Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, HI, IA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.

Lote

ABL800 BASIC: 754R0406N012U ABL800 BASIC with AutoCheck: 754R0742N006 754R0467N002 754R0466N008 754R0467N001 754R0433N011 754R0434N001 754R0437N005 754R0437N006 754R0437N007 754R0436N004 754R0437N001 754R0436N003 754R0436N005 754R0436N006 754R0437N003 754R0437N002 754R0432N003 754R0432N004 754R0432N005 754R0436N002 754R0467N003 754R0276N001 754R1306N002 754R1306N003 754R1308N003 754R1308N005 754R1308N006 754R1309N001 754R1309N005 754R1309N006 754R1309N007 754R1310N001 754R1310N002 754R1310N003 754R1310N004 754R1310N005 754R1310N006 754R1310N007 754R1311N001 754R1311N002 754R1311N003 754R1311N004 754R1311N006 754R1312N001 754R1312N003 754R1312N005 754R0294N008 754R1191N002 754R1191N003 754R1191N004 754R1191N005 754R0400N010 754R0401N001 754R0400N004 754R0400N005 754R0387N012 754R0886N003 754R0886N004 754R0306N001 754R0306N002 754r1098n004 754r1098n006 754R1080N004 754R1080N006 754R1233N004 754R1233N006 754R1211N004 754R1213N001 754R1189N001 754R1189N003 754R1122N002 754R1133N004 754R0999N002 754R0525N011 754R0526N002 754R0526N003 754R0526N004 754R0415N005 754R0415N006 754R0407N006 754R1362N003 754R1363N001 754R1311N005 754R1311N007 754R1239N002 754R1242N008 754R1019N003 754R1019N008 754R0993N009 754R0996N003 754R0967N005 754R0967N007 754R0938N008 754R0939N001 754R0921N004 754R0921N006 754r0809n008 754r0810n001 754R0788N005 754R0787N006 754R0673N005 754R0673N006 754R0673N007 754R0673N008 754R0547N001 754R0547N002 754R0547N003 754R0453N010 754R0454N001 754R0453N011 754R0516N005 754R0516N006 754R0516N007 754R0456N008 754R0457N001 754R0457N002 754R0310N012 754R0259N005 754R0418N010 754R0375N003 754R0375N006 754R0375N004 754R0353N011 754R0353N012 754R1365N003 754R1365N004 754R1365N005 754R1365N007 754R1365N008 754R1233N005 754R1233N007 754R1235N001 754R1235N002 754R1235N004 754R1169N002 754R1169N006 754R1170N001 754R1170N005 754R1170N006 754R1112N006 754R1112N007 754R1116N001 754R1116N002 754R1116N003 754R1050N003 754R1053N004 754R1053N005 754R1053N006 754R1053N007 754R0988N008 754R0988N009 754R0989N002 754R0989N003 754R0989N004 754R0989N005 754R0993N008 754R0921N003 754R0921N005 754R0921N009 754R0922N001 754R0923N003 754R0878N008 754R0878N009 754R0879N001 754R0879N002 754R0879N003 754R0710N001 754R0710N002 754R0710N003 754R0710N004 754R0710N005 754R0703N002 754R0703N005 754R0704N001 754R0704N002 754R0704N003 754R0701N002 754R0701N005 754R0702N003 754R0702N004 754R0702N005 754R0642N002 754R0642N004 754R0642N006 754R0642N007 754R0587N004 754R0586N010 754R0586N008 754R0586N007 754R0498N009 754R0499N009 754R0500N001 754R1242N007 754R0336N004 754R0982N005 754R0458N008 754R0257N006 754R1252N010 754R0454N003 754R0454N004 754R0254N001 754R1166N003 754R1166N004 754R0837N004 754r0569n001 754R0569N002 754R0523N006 754R0401N009 754R0390N002 754R1352N005 754R1353N001 754R1334N002 754R1330N004 754R1319N003 754R1312N002 754R1312N004 754R1284N001 754R1277N007 754R1278N001 754R1258N006 754R1211N005 754R1227N009 754R1205N009 754R1153N003 754R1153N004 754r0375n002 754r0436n011 754R0436N012 754R0439N002 754R1112N005 754R1112N004 754R1099N008 754R1100N002 754R1100N004 754R1100N005 754R0999N005 754R0999N009 754R0971N009 754R0973N008 754R0973N009 754R0951N008 754R0951N009 754R0955N007 754R0947N004 754R0948N001 754R0948N006 754R0948N008 754R0921N001 754R0925N005 754R0854N008 754R0850N009 754R0856N002 754R0850N007 754R0850N008 754R0809N002 754R0809N003 754r0784n006 754R0741N002 754R0741N001 754r0726n009 754R0683N003 754R0683N004 754R0353N010 754R0348N011 754R0348N009 754R0325N012 754R0332N004 754R0332N005 754R0316N005 754R0319N009 754R0320N005 754R0298N002 754R0298N003 754R0303N002 754R0378N007 754R0378N008 754R0378N009 754R0378N010 754R0378N011 754R0378N012 754R0379N001 754R

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States