Roche Diagnostics Operations, Inc.

Hematology and Pathology Devices

2

No

Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.

Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN || The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection of genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1.

Hematology and Pathology Devices

2

No

Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.

Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis, IN || The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human factor II gene, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical samples snd fluorigenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aide to dignosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 instrument using the LightCycler Software 4.05 or 4.1.

LC2C00000032, LC2C00000033, LC2C00000035, LC2C00000060, LC2C00000064, LC2C00000079, LC2C00000080, LC2C00000081, LC2C00000108, LC2C00000110, LC2C00000118, LC2C00000119, LC2C00000120, LC2C00000127, LC2C00000128, LC2C00000130, LC2C00000131, LC2C00000132, LC2C00000133, LC2C00000134, LC2C00000155, LC2C00000156, LC2C00000158, LC2C00000159, LC2C00000162, LC2C00000168, LC2C00000169, LC2C00000170, LC2C00000172, LC2C00000173, LC2C00000178, LC2C00000179, LC2C00000180, LC2C00000192, LC2C00000193, LC2C00000195, LC2C00000196, LC2C00000203, LC2C00000204, LC2C00000205, LC2C00000206, LC2C00000212, LC2C00000213, LC2C00000214, LC2C00000215, LC2C00000216, LC2C00000217, LC2C00000218, LC2C00000219, LC2C00000220, LC2C00000227, LC2C00000228, LC2C00000232, LC2C00000233, LC2C00000234, LC2C00000235, LC2C00000236, LC2C00000242, LC2C00000243, LC2C00000244, LC2C00000250, LC2C00000252, LC2C00000253, LC2C00000254, LC2C00000255, LC2C00000256, LC2C00000263, LC2C00000264, LC2C00000265, LC2C00000266, LC2C00000267, LC2C00000268, LC2C00000269, LC2C00000270, LC2C00000272, LC2C00000273, LC2C00000274, LC2C00000275, LC2C00000276, LC2C00000293, LC2C00000294, LC2C00000298, LC2C00000309, LC2C00000310, LC2C00000312, LC2C00000313, LC2C00000314, LC2C00000329, LC2C00000330, LC2C00000331, LC2C00000358, LC2C00000359, LC2C00000360, LC2C00000361, LC2C00000363, LC2C00000364, LC2C00000381, LC2C00000384, LC2C00000392, LC2C00000393, LC2C00000394, LC2C00000412, LC2C00000413, LC2C00000414, LC2C00000415, LC2C00000418, LC2C00000419, LC2C00000420, LC2C00000427, LC2C00000429, LC2C00000430, LC2C00000431, LC2C00000449, LC2C00000479, LC2C00000483, LC2C00000486, LC2C00000563, LC2C00000571 and LC2C00000578.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.

MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN || MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, total RNA , total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96 well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for making of dilution series, reaction mixes.

62602201

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide distribution.

Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapolis, IN. || For the in vitro quantitative determination of calcium in serum, plasma and urine.

Lots 62601901 and 63020401.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide distribution.

Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. || For the in vitro quantitative determination of calcium in serum, plasma and urine.