Devices

Name Classification Manufacturer Risk Class Country Source
cobas hiv-1 test for use on the cobas 4800 system; cobas hbv test for use on the cobas 4800 system ROCHE DIAGNOSTICS Italy
tsh ROCHE DIAGNOSTICS Italy
Anti-hav ROCHE DIAGNOSTICS Italy
multiplate analyzers ROCHE DIAGNOSTICS Italy
precicontrol varies ROCHE DIAGNOSTICS Italy
cobas b 123 <3> poc system, software system 4.7 cobas b 123 poc system - 05122279001, 05064694001 ROCHE DIAGNOSTICS Italy
glu / lac / urea (bun) cassettes ROCHE DIAGNOSTICS Italy
cobas c 111 analyzers ROCHE DIAGNOSTICS Italy
rack trays ROCHE DIAGNOSTICS Italy
assaytip / assaycup ROCHE DIAGNOSTICS Italy
a1c-2 ROCHE DIAGNOSTICS Italy
urine strips. see attachment. ROCHE DIAGNOSTICS Italy
cobas b123 <3> poc system, cobas b123 <4> poc system ROCHE DIAGNOSTICS Italy
online tdm gentamicin 100 tests c 311, c 501/502; online tdm gentamicin 100 tests c 701/702; online tdm gentamicin mod p ROCHE DIAGNOSTICS Italy
online tdm vancomycin 100 tests; online tdm vancomycin 200 tests; hitachi vancomycin (911, 912, 917, p); hitachi vancomycin (917, p) ROCHE DIAGNOSTICS Italy
cobas egfr mutation test v2 ROCHE DIAGNOSTICS Italy
estradiol iii, estradiol ii ROCHE DIAGNOSTICS Italy
cobas p 512 pre-analytical system ROCHE DIAGNOSTICS Italy
accu-chek inform ii base units; handheld base unit ROCHE DIAGNOSTICS Italy
cobas b 123 <4> poc system ROCHE DIAGNOSTICS Italy
bulk loader module pre-analytical system for cobas p 471 (model no. 07084285001) bulk loader module pre- analytical system for cobas p 512/612 (model no. 07135645001) - 07084285001; 07135645001 ROCHE DIAGNOSTICS Italy
cobas 6800 system, cobas 8800 system ROCHE DIAGNOSTICS Italy
reflotron uric acid ROCHE DIAGNOSTICS Italy
cobas b 123 fluid pack 200; cobas b 123 fluid pack 400; cobas b 123 fluid pack 700; cobas b 123 fluid pack coox 200; cobas b 123 fluid pack coox 400 ROCHE DIAGNOSTICS Italy
s3 fluid packs a ROCHE DIAGNOSTICS Italy