Ventana Medical Systems Inc

16 devices in the database

  • Model / Serial
    Lot number: B01057A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.
  • Product Description
    iView DAB Detection Kit, Part number: 760-091 || (05266157001) || This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
  • Model / Serial
    Lot number: A05885 & B00988
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.
  • Product Description
    ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) || This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
  • Model / Serial
    Cat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the market).
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Germany.
  • Product Description
    VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only || Product Usage: || Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
  • Model / Serial
    Cat#750-600; PN 05342716001; Serial #'s: 310724, 310735, 311187, 312055, 310373, 311052, 311171, 311953, 310750, 311266, 311267, 311564, 311565, 311596, 311304, 310481, 311924, 310607, 311627, 310527, 311436, 311742, 310132, 311432, 310034, 310408, 310687, 310697, 311343, 311958, 310728, 310778, 311991, 312070, 310471, 311326, 311952, 310103, 310777, 311446, 310924, 311303, 311528, 310490, 310913, 311529, 311494, 310139, 310281, 310465, 310275, 310617, 310665, 310716, 311853, 311871, 312137, 312101, 310240, 310237,310238, 311571, 311404, 310356, 310023, 312164, 312165, 310065, 310231, 310711, 310706, 310707, 310703, 311509, 310330, 310633, 311811, 311810, 310977, 311194, 311198, 310208, 310732, 310740, 310187, 311462, 311935, 310145, 311037, 310346, 310585, 310694, 310699, 310701,  310702, 310705, 310709, 310710, 310704, 311106, 311110, 311111, 311419, 311484, 311527, 310345, 311381, 311353, 310480, 311869, 311921, 311458, 310315, 310412, 311988, 310618, 310397, 310399, 311868, 311919, 312139, 312141, 312142, 311270, 310069, 311466, 311929, 310083, 310094, 310154, 311904, 310588, 312098, 312100, 310814, 311731, 311783, 311785, 312096, 312104, 312153, 310227, 310781, 310174, 311403, 311080, 311081, 311121, 311122, 311169, 311188, 311189, 311190, 311242, 311245, 311298, 311926, 310403, 310718, 311416, 311417, 312105, 312112, 310796, 310832, 310824, 311135, 311248, 312066, 310895, 310267, 310272, 311481, 311771, 311772, 310882, 311186, 311937, 310344, 311439, 311505, 310146, 310506, 311545, 310446, 310312, 311584, 312124, 310839, 311319, 311261, 310070, 310508, 311367, 311578, 311576, 311629, 311601, 311600, 311607, 311603, 311602, 311606, 311598, 311597, 311604, 311605, 311599, 311272, 312145, 312123, 310339, 310455, 310472, 310478, 310482, 311562, 311560, 311923, 311498, 311814, 311813, 311804, 310020, 310844, 311313, 311533, 310779, 311241, 311750, 310268, 310331, 311221, 311036, 311034, 311035, 310201, 310321, 310792, 312056, 311147, 311153, 311315, 311308, 310641, 310678, 310878, 310032, 311774, 311182, 310390, 311151, 311268, 311284, 311552, 310902, 311455, 310491, 311038, 312008, 310282, 310696, 311735, 310173, 310402, 311710, 312118, 311874, 310972, 311375, 311727, 312128, 312134, 310933,  310921, 311285, 310297, 310769, 311876, 310916, 311486, 310460, 310245, 310576, 311483, 312097, 312099, 312089, 312109, 311518, 311479, 311901, 312144, 312172, 311551, 310555, 310363, 311808, 310570, 311001, 310358, 310492, 311252, 311687, 311672, 311402, 310114, 310122, 310126, 311300, 310794, 311350, 311592, 310749, 310285, 311299, 310897, 311323, 310258, 310467, 310470, 311628, 310943, 310035, 310066, 310087, 310185, 310752, 310757, 311134, 312138, 310489, 311973, 311191, 310456, 310575, 310673, 310683, 310890, 310821, 312170, 312171, 312060, 312102, 312202, 310500, 310505, 311394, 311917, 311511, 311530, 310894, 312136, 311369, 311665, 312152, 310804, 311517, 311465, 310893, 310896, 311946, 311947, 310323, 310776, 310654, 310299, 310452, 311675, 310404, 310810, 310708, 310712, 311073, 311250, 310910, 311401, 311928, 310941, 310026, 310089, 310336, 310341, 311736, 311610, 311608, 311609, 311728, 310820, 311821, 310141, 310912, 311443, 311442, 311243, 311207, 310256, 310378, 310229, 312163, 312058, 310771, 311103, 310915, 310533, 310124, 311318, 310218, 310811, 311738, 310037, 310038, 310365, 310377, 311210, 312085, 312086, 312087, 311295, 312023, 311493, 311357, 310833, 310800, 311464, 311423, 311173, 311364, 310135, 310608, 310935, 311352, 311354, 311356, 310920, 310183, 310257, 310306, 310852, 311431, 310876, 311949, 311956, 310828, 310830, 310928, 310929, 310930, 310355, 310271, 311384, 312122, 310846, 311345, 310119, 310391, 310881, 310483, 310488, 311893, 312063, 310284, 311663, 312131, 310374, 310507, 310144, 310775, 311730, 311939, 310106, 310205, 310241, 310620, 310713, 310031, 310742, 311016, 311463, 310445, 312117, 310906, 311376, 311377, 311378, 311379, 311380, 310288, 311334, 311957, 311714, 310898, 311477, 310210, 310224, 311033, 312076, 312078, 312090, 310632, 312116, 310751, 310249, 311468, 310923, 310123, 311760, 310180, 311160, 310905, 310605, 310458, 311925, 310822, 311485, 311503, 311500, 311474, 310879, 312061, 310189, 310191, 312039, 312051, 312052, 312059, 312188, 311948, 311072, 310182, 310503, 310922, 311172, 311461, 311324, 311209, 310799, 310807, 310314, 310855, 312127, 310084, 310165, 311322, 311321, 310573, 310572, 311559, 310375, 310181, 310308, 312103, 312077, 312106, 312107, 312108, 310474, 310486, 312021, 312167, 312169, 311247, 310634, 310461, 312203, 310730, 310729, 311065, 311348, 311346, 311332, 310763, 312126, 310036, 310348, 310362, 311395, 311459, 311472, 311236, 311450, 311451, 310884, 311118, 311887, 311337, 311338, 310842, 310028, 310318, 310479, 311773, 311259, 311679, 312009, 312012, 310283, 310453, 310501, 310663, 310889, 310715, 311482, 311183, 311184, 310610, 311520, 311506, 310369, 310770, 310351, 310827, 310497, 311006, 311399, 311040, 311355, 312132, 312133, 311510, 310410, 312088, 311407, 310043, 310044, 310045, 310818, 310085, 311120, 311918, 311989, 311117, 310179, 311105, 311049, 312176, 310099, 311563, 310100, 310190, 311823, 310058, 310061, 310864, 311389, 310805, 310048, 311911, 311425, 311146, 310228, 310260, 311534, 310736, 310738, 310722, 311223, 310128, 310137, 310059, 312140, 311471, 311519, 310831, 310120, 311307, 310806, 311902, 310319, 311798, 311802, 312129, 312130, 311076, 311139, 311132, 311181, 311496, 311507, 312147, 312154, 310762, 310447, 311168, 310466, 311619, 311617, 310451, 311415, 311756, 312048, 311149, 310892, 311488, 311491, 311238, 311531, 311801, 311898, 311934, 310101, 310142, 311532, 311317, 311341, 310637, 311310, 311237, 310880, 311420, 312053, 311940, 311941, 311951, 311467, 310209, 310817, 311708, 310413, 311755, 310462, 310464, 311927, 311697, 310354, 312057, 311041, 311115, 311492, 311441, 310195, 310125, 310194, 310223, 310222, 310279, 310469, 310795, 310326, 311502, 311192, 311039, 311051, 311385, 310405, 311764, 310850, 311413, 310825, 310743, 310744, 310785, 310801, 310802, 310280, 310303, 311251, 311406, 311200, 311333, 310401, 311271, 310325, 311920, 310793, 310684, 310068, 311262, 311264, 310109, 311161, 311487, 312119, 311834, 311950, 311729, 311437, 311444, 312054, 311053, 311046, 311193, 310649, 310392, 311860, 310409, 312120, 312121, 311104, 311892, 310812, 310996, 310556, 311936, 310739, 311677, 312064, 312065, 312110, 312113, 310883, 311907, 311945, 310639, 311900, 310564, 311522, 311535, 311239, 311240, 310809, 311296, 311843, 311454, 311480, 310476, 312095, 311997, 311820, 310566, 311784, 311258, 310192, 310758, 311818, 311899, 311201, 311382, 310843, 310733, 310734, 311712, 311440, 311150, 310937, 310737, 310680, 310829, 311430, 310609, 310741, 311246, 311253, 311342, 310545, 310568, 311699, 311698, 310939, 310942, 310496, 310907, 311909, 310692, 310926, 310534, 311269, 310838, 310327, 311852, 312111, 310891, 310062, 310172, 310834, 310463, 310502, 310914, 311944, 311021, 310316, 311695, 311703, 311805, 311806, 311807, 311809, 312003,311005, 310885, 311752, 311751, 311732, 312150, 311942, 312026, 310676, 310225, 310353, 310473, 310475, 311508, 310717, 311089, 311148, 311138, 311140, 311141, 311320, 310454, 312143, 310593, 310591, 310657, 312081, 312125, 310226, 310611, 311349, 312151, 310322, 310064, 310748, 310216, 310494, 310495, 311029, 310217, 312016, 311775, 311777, 310443, 310597, 310603, 310602, 310606, 310360, 310130, 310131, 310133, 310143, 311178, 310138, 310140, 310276, 311792, 311504, 311501, 311499, 310411, 310621, 310690, 310727, 311249, 311288, 311400, 311418, 311457, 311470, 311696, 311694, 311693, 311309, 310040, 310681, 310823, 310798, 311056, 310416, 311408, 311344, 311906, 311624, 312017, 312033, 311943, 311048, 311409, 311495, 311758, 311093, 311447, 311885, 310367, 311489, 310352, 311975, 311977, 311339, 310376, 310379, 311653, 311199, 310385, 310414, 310485, 311260, 310244, 311365, 311366, 310324, 310033, 310304, 312010, 312011, 310918, 310919, 312007, 310156, 310819, 311765, 311490, 311351, 311063, 310899, 310903, 311022, 311025, 311088, 310660, 311274, 312146, 310027, 310909, 311922, 310134, 310041, 310232, 310613, 311497, 312062, 311575, 311740, 311970, 310538, 310644, 310873, 311822, 311536, 311980, 310188, 310574, 311383, 310925, 310958, 310960, 311030, 311019, 311179, 311180, 310121, 311087, 310877, 310449, 310450, 310487, 311515, 311427, 311516, 311452, 310219, 310239, 312203 All serial numbers in the market
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Germany.
  • Product Description
    VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only || Product Usage: || Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
  • Model / Serial
    UDI 04015630970254, Lot Number: Y15392
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,
  • Product Description
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
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13 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85737
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
8 more