VITROS 5,1

Software Version 2.8 & Below; VITROS 5,1 FS Chemistry System Serial Numbers 34000119 - 34002323; VITROS 5,1 Refurbished: Serial Numbers - Domestic S/Ns: 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000464, 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, 34001311, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897; Foreign S/Ns: 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, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844,  34000846, 34000852, 34000856, 34000870, 34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938, 34000956, 34000969, 34000976,  34001007, 34001009, 34001044, 34001045, 34001071, 34001075, 34001098,  34001099, 34001111, 34001129, 34001154, 34001161, 34001171, 34001182,  34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,  34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,  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, 34001790, 34001796, 34001810, 34001822, 34001831, 34001833,  34001849, 34001855, 34001859, 34001860, 34001867, 34001871, 34001872,  34001881, 34001905, 34001916, 34001923, 34001995. --- PLEASE NOTE: The serial numbers are sequential, but not all analyzers are released for distribution. Therefore, the amount of each system manufactured may not equal the amount of each system distributed.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.

Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. || Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.

Software Versions 2.2.1 through 2.8; Catalog # 6801375 Serial Numbers: 34000119 through 34002323; Catalog # 6801890 Serial Numbers: J34000133, J34000193, J34000197, J34000212, J34000285, J34000316, J34000318, J34000337, J34000360, J34000420, J34000451, J34000478, J34000495, J34000497, J34000529, J34000538, J34000552, J34000557, J34000590, J34000596, J34000601, J34000631, J34000642, J34000761, J34000799, J34000805, J34000833, J34000851, J34000893, J34000946, J34000947, J34001006, J34001172, J34001218, J34001240, J34001243, J34001248, J34001251, J34001274, J34001297, J34001311, J34001317, J34001345, J34001378, J34001379, J34001389, J34001390, J34001396, J34001422, J34001472, J34001504, J34001569, J34001572, J34001612, J34001626, J34001633, J34001668, J34001755, J34001809, J34001840, J34001850, J34001875, J34001897.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.

VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics Inc. || The VITROS 5,1 FS Chemistry System with enGEN Laboratory Automation 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.)

Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - 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, 34001311, 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, 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.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.

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, Software Version 2.8 and below, 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.).

In-vitro diagnostics - equipment / products for clinical chemistry

VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and VITROS 5600 Integrated System, Ortho-Clinical Diagnostics Inc