Devices

Vitros

  • 모델명 / 제조번호(시리얼번호)
    All Vitros ECi units currently on the market (software version 3.1 or lower).
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
  • 제품 설명
    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event

제조사

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA

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Device Recall VITROS 250 Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Software Version 9.4 and below; VITROS 250 Serial Numbers: 25010043 - 25055306; VITROS 250 Refurbished Serial Numbers: 25010582, 25010617, 25010638, 25010782, 25011056, 25011074, 25011176, 25011192, 25011196, 25011246, 25011317, 25011383, 25011408, 25011435, 25011448, 25011517, 25011647, 25011648, 25011777, 25011957, 25012025, 25012058, 25012062, 25012073, 25012078, 25012140, 25012259, 25012267, 25012323, 25012344, 25012487, 25012505, 25012521, 25012574, 25012629, 25012654, 25012672, 25012765, 25012782, 25012838, 25012931, 25012938, 25013036, 25013100, 25013139, 25013216, 25013245, 25013313, 25013389, 25013391, 25013448, 25013473, 25013497, 25013583, 25013597, 25013719, 25013757, 25013787, 25013790, 25013870, 25013879, 25013971, 25013982, 25014033, 25014196, 25014201, 25014209, 25014272, 25014278, 25014286, 25014318, 25014404, 25014409, 25014412, 25014448, 25014449, 25014459, 25014562, 25014609, 25014610, 25014655, 25014657, 25014663, 25014728, 25014741, 25014775, 25014788, 25014832, 25014849, 25014927, 25015076, 25015132, 25015133, 25015169, 25015223, 25015242, 25015277, 25015389, 25015430, 25015445, 25015463, 25015678, 25015770, 25015847, 25015914, 25015915, 25015976, 25015990, 25015998, 25016011, 25016177, 25016218, 25016429, 25016463, 25016517, 25016528, 25016552, 27000025, 27000054, 27000132, 27000156, 27000216, 27000317, 27000488, 27000870, 27000936, 27001058, 27001124, 27001471, 27001644, 27001651, 27001763, 27002256, 27002351, 27002714, R2500159, R2500179, R2500217, 25010122, 25010187, 25010220, 25010320, 25010332, 25010360, 25010362, 25010380, 25010394, 25010429, 25010450, 25010465, 25010522, 25010584, 25010648, 25010677, 25010690, 25010691, 25010694, 25010697, 25010709, 25010713, 25010719, 25010725, 25010735, 25010749, 25010751, 25010753, 25010770, 25010772, 25010774, 25010775, 25010802, 25010809, 25010817, 25010841, 25010845, 25010848, 25010850, 25010859, 25010864, 25010865, 25010867, 25010872, 25010885, 25010889, 25010908, 25010919, 25010923, 25010949, 25010954, 25010955, 25010962, 25010965, 25010970, 25010996, 25011018, 25011030, 25011031, 25011043, 25011061, 25011072, 25011078, 25011083, 25011107, 25011109, 25011126, 25011131, 25011133, 25011161, 25011179, 25011187, 25011205, 25011208, 25011230, 25011231, 25011243, 25011247, 25011255, 25011256, 25011274, 25011278, 25011283, 25011324, 25011341, 25011345, 25011356, 25011361, 25011362, 25011372, 25011384, 25011385, 25011388, 25011390, 25011392, 25011393, 25011407, 25011424, 25011436, 25011441, 25011446, 25011456, 25011462, 25011466, 25011473, 25011476, 25011479, 25011482, 25011500, 25011501, 25011508, 25011513, 25011521, 25011525, 25011533, 25011535, 25011541, 25011553, 25011556, 25011565, 25011569, 25011599, 25011610, 25011619, 25011624, 25011627, 25011631, 25011649, 25011650, 25011673, 25011678, 25011679, 25011684, 25011698, 25011701, 25011709, 25011710, 25011712, 25011719, 25011729, 25011732, 25011743, 25011749, 25011751, 25011759, 25011780, 25011783, 25011785, 25011795, 25011797, 25011816, 25011817, 25011826, 25011834, 25011836, 25011845, 25011852, 25011854, 25011868, 25011872, 25011878, 25011880, 25011881, 25011887, 25011891, 25011900, 25011904, 25011922, 25011937, 25011940, 25011949, 25011956, 25011960, 25011964, 25011965, 25011966, 25011968, 25011983, 25011985, 25011987, 25011988, 25012001, 25012002, 25012004, 25012015, 25012016,  25012017, 25012024, 25012029, 25012042, 25012043, 25012044, 25012052, 25012053, 25012056, 25012065, 25012066, 25012074, 25012087, 25012090, 25012102, 25012105, 25012111, 25012115, 25012118, 25012127, 25012134, 25012155, 25012169, 25012192, 25012193, 25012196, 25012221, 25012227, 25012231, 25012242, 25012262, 25012264, 25012270, 25012274, 25012283, 25012298, 25012301, 25012302, 25012310, 25012312, 25012313, 25012325, 25012336, 25012351, 25012357, 25012360, 25012371, 25012379, 25012380, 25012391, 25012404, 25012411, 25012418, 25012421, 25012422, 25012429, 25012431, 25012436, 25012444, 25012445, 25012464, 25012467, 25012478, 25012479, 25012480, 25012481, 25012482, 25012483, 25012485, 25012489, 25012494, 25012504, 25012506, 25012511, 25012512, 25012514, 25012525, 25012545, 25012547, 25012552, 25012579, 25012582, 25012597, 25012614, 25012624, 25012626, 25012628, 25012641, 25012648, 25012651, 25012652, 25012653, 25012655, 25012656, 25012657, 25012658, 25012660, 25012661, 25012663, 25012680, 25012707, 25012710, 25012718, 25012723, 25012726, 25012728, 25012733, 25012735, 25012736, 25012742, 25012751, 25012775, 25012779, 25012784, 25012786, 25012791, 25012793, 25012803, 25012806, 25012808, 25012821, 25012836, 25012843, 25012861, 25012878, 25012879, 25012883, 25012886, 25012888, 25012897, 25012903, 25012906, 25012914, 25012921, 25012924, 25012927, 25012930, 25012937, 25012939, 25012941, 25012943, 25012950, 25012951, 25012952, 25012956, 25012966, 25012971, 25012974, 25012976, 25012985, 25012988, 25012995, 25013001, 25013002, 25013006, 25013009, 25013010, 25013015, 25013019, 25013020, 25013021, 25013025, 25013033, 25013037, 25013042, 25013045, 25013054, 25013063, 25013068, 25013073, 25013074, 25013075, 25013091, 25013110, 25013114, 25013119, 25013124, 25013151, 25013155, 25013157, 25013174, 25013185, 25013205, 25013207, 25013210, 25013219, 25013222, 25013230, 25013236, 25013239, 25013241, 25013244, 25013248, 25013258, 25013265, 25013272, 25013273, 25013278, 25013279, 25013282, 25013284, 25013297, 25013303, 25013312, 25013314, 25013315, 25013316, 25013318, 25013331, 25013332, 25013334, 25013335, 25013336, 25013354, 25013362, 25013364, 25013374, 25013376, 25013383, 25013386, 25013388, 25013393, 25013398, 25013413, 25013416, 25013424, 25013440, 25013441, 25013443, 25013444, 25013456, 25013459, 25013472, 25013478, 25013483, 25013484, 25013488, 25013491, 25013492, 25013496, 25013505, 25013508, 25013511, 25013522, 25013531, 25013539, 25013544, 25013545, 25013549, 25013558, 25013559, 25013561, 25013562, 25013563, 25013564, 25013568, 25013573, 25013580, 25013581, 25013582, 25013584, 25013589, 25013592, 25013599, 25013601, 25013603, 25013612, 25013615, 25013617, 25013622, 25013623, 25013631, 25013632, 25013637, 25013659, 25013662, 25013665, 25013666, 25013668, 25013669, 25013670, 25013673, 25013675, 25013679, 25013689, 25013693, 25013694, 25013697, 25013707, 25013713, 25013715, 25013717, 25013718, 25013732, 25013733, 25013736, 25013737, 25013739, 25013747, 25013755, 25013766, 25013772, 25013773, 25013775, 25013776, 25013779, 25013793, 25013812, 25013814, 25013820, 25013824, 25013825, 25013826, 25013834, 25013840,  25013844, 25013847, 25013859, 25013862, 25013867, 25013869, 25013873, 25013876, 25013878, 25013881, 25013882, 25013887, 25013888, 25013890, 25013894, 25013900, 25013904, 25013907, 25013908, 25013909, 25013915, 25013916, 25013917, 25013932, 25013935, 25013938, 25013940, 25013945, 25013954, 25013957, 25013958, 25013959, 25013967, 25013968, 25013969,  25013972, 25013979, 25013980, 25013987, 25013988, 25013989, 25013994, 25014011, 25014012, 25014016, 25014020, 25014024, 25014031, 25014037, 25014047, 25014050, 25014051, 25014055, 25014057, 25014060, 25014065, 25014067, 25014072, 25014074, 25014087, 25014093, 25014097, 25014100, 25014109, 25014119, 25014121, 25014126, 25014127, 25014129, 25014130,  25014131, 25014137, 25014149, 25014155, 25014169, 25014172, 25014173, 25014174, 25014182, 25014191, 25014193, 25014194, 25014199, 25014211, 25014222, 25014223, 25014226, 25014236, 25014239, 25014244, 25014245, 25014250, 25014252, 25014260, 25014263, 25014265, 25014274, 25014276, 25014277, 25014279, 25014281, 25014288, 25014309, 25014310, 25014311,  25014319, 25014322, 25014325, 25014330, 25014343, 25014357, 25014366, 25014376, 25014378, 25014380, 25014384, 25014386, 25014390, 25014391, 25014392, 25014425, 25014426, 25014432, 25014435, 25014441, 25014452, 25014467, 25014468, 25014469, 25014477, 25014479, 25014489, 25014503, 25014507, 25014517, 25014518, 25014529, 25014539, 25014541, 25014551,  25014566, 25014567, 25014573, 25014578, 25014580, 25014582, 25014603, 25014604, 25014613, 25014617, 25014620, 25014627, 25014628, 25014630, 25014631, 25014638, 25014650, 25014654, 25014674, 25014677, 25014696, 25014697, 25014707, 25014714, 25014715, 25014716, 25014717, 25014719, 25014725, 25014730, 25014737, 25014738, 25014739, 25014747, 25014763, 25014765, 25014767, 25014769, 25014771, 25014783, 25014787, 25014789, 25014796, 25014805, 25014807, 25014821, 25014823, 25014824, 25014826, 25014827, 25014831, 25014834, 25014838, 25014840, 25014841, 25014843, 25014844, 25014851, 25014855, 25014856, 25014857, 25014858, 25014865, 25014866, 25014877, 25014878, 25014886, 25014887, 25014888, 25014889,  25014893, 25014896, 25014899, 25014902, 25014905, 25014908, 25014923, 25014924, 25014935, 25014938, 25014939, 25014940, 25014942, 25014947, 25014951, 25014952, 25014958, 25014970, 25014973, 25014974, 25014977, 25014979, 25014984, 25014986, 25014992, 25014994, 25014995, 25014998, 25015004, 25015013, 25015014, 25015019, 25015029, 25015031, 25015039,  25015042, 25015044, 25015048, 25015053, 25015055, 25015063, 25015068, 25015075, 25015086, 25015090, 25015093, 25015099, 25015105, 25015108, 25015112, 25015120, 25015126, 25015137, 25015139, 25015140, 25015141, 25015147, 25015160, 25015161, 25015165, 25015171, 25015192, 25015205, 25015215, 25015216, 25015218, 25015225, 25015231, 25015235, 25015236,  25015239, 25015240, 25015249, 25015256, 25015257, 25015259, 25015261, 25015267, 25015274, 25015284, 25015291, 25015293, 25015294, 25015296, 25015299, 25015307, 25015310, 25015311, 25015318, 25015319, 25015321, 25015323, 25015326, 25015338, 25015339, 25015342, 25015350, 25015351, 25015353, 25015354, 25015355, 25015358, 25015359, 25015360, 25015367, 25015372, 25015373, 25015378, 25015381, 25015382, 25015386, 25015387, 25015393, 25015404, 25015405, 25015408, 25015413, 25015415, 25015416, 25015424, 25015425, 25015433, 25015435, 25015441, 25015452, 25015467, 25015477, 25015483, 25015484, 25015487, 25015503, 25015513, 25015518, 25015521, 25015529, 25015559, 25015566, 25015577, 25015578, 25015585,  25015589, 25015590, 25015597, 25015600, 25015603, 25015610, 25015611, 25015612, 25015614, 25015625, 25015633, 25015634, 25015639, 25015641, 25015644, 25015645, 25015650, 25015654, 25015658, 25015661, 25015670, 25015671, 25015674, 25015676, 25015682, 25015685, 25015690, 25015699, 25015702, 25015704, 25015705, 25015710, 25015712, 25015713, 25015717,  25015723, 25015734, 25015736, 25015739, 25015741, 25015742, 25015757, 25015763, 25015764, 25015765, 25015782, 25015783, 25015787, 25015788, 25015789, 25015803, 25015807, 25015808, 25015811, 25015812, 25015814, 25015817, 25015824, 25015825, 25015837, 25015842, 25015846, 25015851, 25015856, 25015859, 25015860, 25015863, 25015871, 25015874, 25015875,  25015878, 25015879, 25015882, 25015889, 25015894, 25015898, 25015904, 25015912, 25015913, 25015923, 25015924, 25015935, 25015938, 25015946, 25015958, 25015963, 25015965, 25015969, 25015970, 25015973, 25015981, 25015983, 25015985, 25016000, 25016009, 25016012, 25016019, 25016021, 25016030, 25016037, 25016039, 25016041, 25016045, 25016048, 25016049, 25016051, 25016053, 25016054, 25016058, 25016063, 25016069, 25016073, 25016086, 25016087, 25016088, 25016095, 25016102, 25016104, 25016108, 25016113, 25016115, 25016116, 25016118, 25016120, 25016126, 25016128, 25016142, 25016149, 25016151, 25016159, 25016164, 25016172, 25016176, 25016181, 25016215, 25016231, 25016234, 25016240, 25016241, 25016242,  25016255, 25016268, 25016273, 25016276, 25016290, 25016298, 25016299, 25016301, 25016305, 25016309, 25016316, 25016324, 25016325, 25016333, 25016337, 25016357, 25016360, 25016361, 25016368, 25016384, 25016391, 25016392, 25016404, 25016407, 25016411, 25016414, 25016418, 25016426, 25016428, 25016431, 25016433, 25016437, 25016441, 25016443, 25016446,  25016452, 25016453, 25016458, 25016461, 25016467, 25016474, 25016479, 25016480, 25016486, 25016490, 25016492, 25016494, 25016495, 25016497, 25016511, 25016514, 25016524, 25016549, 25016551, 25016556, 25016557.25016558, 25016563, 25016566, 25016573, 25016580, 25016582, 25016586, 25016589, 25016594, 25016595, 25016596, 25016602, 25016604, 25016613,  25016619, 25016620, 25016637, 25016638, 25016644, 25016647, 25016649, 25016650, 25016670, 25016804, 25016818, 25016837, 25016838, 25016852, 25016899, 25016912, 25016916, 25016917, 25016918, 25016919, 25016932, 25016940, 25016943, 25016944, 25016946, 25016947, 25016950, 25016951, 25016952, 25016953, 25016957, 25016958, 25104774, 27000004, 27000006,  27000007, 27000008, 27000009, 27000010, 27000016, 27000018, 27000022, 27000041, 27000051, 27000052, 27000058, 27000061, 27000063, 27000070, 27000072, 27000075, 27000080, 27000089, 27000103, 27000106, 27000110, 27000112, 27000115, 27000126, 27000133, 27000134, 27000135, 27000136, 27000146, 27000147, 27000148, 27000164, 27000165, 27000175, 27000181,  27000183, 27000192, 27000203, 27000205, 27000206, 27000208, 27000209, 27000217, 27000223, 27000224, 27000227, 27000233, 27000244, 27000273, 27000281, 27000287, 27000289, 27000290, 27000300, 27000303, 27000304, 27000309, 27000313, 27000316, 27000324, 27000326, 27000328, 27000333, 27000350, 27000351, 27000355, 27000357, 27000362, 27000369, 27000372,  27000373, 27000374, 27000382, 27000383, 27000384, 27000389, 27000409, 27000415, 27000418, 27000421, 27000424, 27000427, 27000436, 27000448, 27000450, 27000453, 27000456, 27000457, 27000467, 27000470, 27000471, 27000477, 27000479, 27000483, 27000484, 27000489, 27000492, 27000507, 27000515, 27000516, 27000529, 27000538, 27000540, 27000546, 27000568,  27000581, 27000584, 27000598, 27000606, 27000607, 27000624, 27000627, 27000652, 27000655, 27000658, 27000660, 27000662, 27000663, 27000677, 27000678, 27000680, 27000683, 27000686, 27000696, 27000709, 27000713, 27000714, 27000716, 27000717, 27000718, 27000719, 27000740, 27000745, 27000758, 27000769, 27000777, 27000779, 27000784, 27000787, 27000790,  27000791, 27000796, 27000797, 27000806, 27000813, 27000814, 27000824, 27000835, 27000847, 27000854, 27000861, 27000862, 27000869, 27000872, 27000873, 27000874, 27000875, 27000877, 27000880, 27000881, 27000882, 27000894, 27000903, 27000908, 27000912, 27000924, 27000926, 27000927, 27000928, 27000930, 27000947, 27000948, 27000949, 27000958, 27000961, 27000963, 27000964, 27000984, 27000988, 27000994, 27001005, 27001006, 27001007, 27001021, 27001032, 27001061, 27001066, 27001087, 27001089, 27001091, 27001093, 27001094, 27001103, 27001104, 27001123, 27001139, 27001144, 27001145, 27001166, 27001167, 27001170, 27001177, 27001183, 27001185, 27001187, 27001193, 27001202, 27001205, 27001212, 27001213, 27001221, 27001223, 27001229, 27001234, 27001236, 27001240, 27001241, 27001279, 27001283, 27001289, 27001304, 27001319, 27001326, 27001334, 27001337, 27001353, 27001360, 27001361, 27001364, 27001366, 27001381, 27001400, 27001402, 27001418, 27001426, 27001429, 27001434, 27001448, 27001473, 27001497, 27001520, 27001524, 27001525, 27001526, 27001531,  27001533, 27001535, 27001552, 27001556, 27001559, 27001565, 27001599, 27001612, 27001639, 27001645, 27001646, 27001647, 27001660, 27001662, 27001667, 27001670, 27001692, 27001693, 27001694, 27001696, 27001698, 27001729, 27001741, 27001766, 27001772, 27001785, 27001796, 27001802, 27001806, 27001871, 27001901, 27001905, 27001912, 27001934, 27001952,  27001953, 27001968, 27001975, 27002013, 27002018, 27002028, 27002044, 27002134, 27002136, 27002151, 27002183, 27002245, 27002304, 27002350, 27002352, 27002521, 27002526, 27002557, 27002652, 27002663, 25010717A, R2500004, R2500011, R2500028, R2500033, R2500037, R2500041, R2500044, R2500050, R2500063, R2500081, R2500087, R2500125, R2500140, R2500146, R2500147, R2500149, R2500155, R2500158, R2500173, R2500183, R2500188, R2500189, R2500191, R2500232
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • 제품 설명
    VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
  • Manufacturer
    Ortho-Clinical Diagnostics
Device Recall VITROS 350 Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Software Version 9.4 and below; Serial Numbers J27000001 - 27004539
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • 제품 설명
    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
  • Manufacturer
    Ortho-Clinical Diagnostics
Device Recall VITROS 4600 Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Software Version 3.2 and below; Serial Numbers J46000001 - 46000678
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • 제품 설명
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
  • Manufacturer
    Ortho-Clinical Diagnostics
Device Recall VITROS 5600 Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Software Version 3.2 and below; Serial Numbers J56000024 - 56002339
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • 제품 설명
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics
Device Recall VITROS 5,1 FS Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000119 - J34002323; VITROS 5,1 FS Chemistry System (Refurbished) Serial Numbers: 34000133, 34000193, 34000197, 34000212,  34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557,  34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799,  34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006,  34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274,  34001297, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850,  34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219,  34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431,  34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541,  34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617,  34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744,  34000745, 34000755, 34000759, 34000767, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870,  34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938,  34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045,  34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129,  34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201,  34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,  34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,  34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367,  34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423,  34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551, 34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594,  34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693,  34001725, 34001738, 34001745, 34001747, 34001790, 34001796, 34001798,  34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859,  34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916,  34001923, 34001995
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • 제품 설명
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. || Product Usage: || The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
  • Manufacturer
    Ortho-Clinical Diagnostics
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