Roche Diagnostics Operations, Inc.

Lot number: 70002500

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.

Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. || For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants

Lot Number 470049, expiration date 12/31/2011.

Clinical Chemistry and Clinical Toxicology Devices

2

No

No US distribution, in France Only.

ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.

Series 1.0 software version 3.0.11, Part number 12236931001, Ser Numbers 28KN9Z70VE, LCPG0398, US03910905, US94800252, LCPD0020, LCPF0163, LCPG1291, LCPG1291, MXL5040CBZ, LCPE0042, CZC5252BDQ, LCPG1314, 2UA40207G6, LCPG0723, FRB3270KYX, LCPG0876, CZC5240354, US14111136, LCPG0426, USC326024W, LCPG0627, 29KN9ZP27C, LCPG0492, FRB3270H1D, LCPG0952, 2UA402049J, LCPG0711, LCPG0431, LCPG1070, LCPG0431, LCPG1070, USC3260241, USC3260241, CZC52403GR, CZC52403GR, CZC5252BDC, CZC5252BDC, LCPG0613, LCPG0613, LCPG1041, LCPG1041, CZC5251H2N, FRB3270JV7, FRB3270L5Y, LCPG0955, LCPG0956, 70018557, LCPG1252, FRB3270LQJ, LCPG0976, FRB3270KCK, LCPG0950, US14111105, CZC5231GH2, LCPG0320, LCPG1143, 2UA33504CM, LCPG0654, 2UB3370CMH, LCPG0689, 2UA4110GFH, MXL5310FQ7, CZC5251H5Z, LCPG0807, LCPG1161, LCPG1290, LCPG1290, US14110908, CZC5251G3F, LCPG0244, US10570146, CZC52402Y9, LCPF0131, US03910992, LCPF0178, USC325070Z, USU32703WY, LCPG0629, LCPG0663, USU32703WZ, LCPG0664, 28KN9ZK0Y9, CZC5252B9Z, LCPG0427, CZC521G1L, LCPG1071, FRB3270LQL, LCPG0983, LCPG1176, FRB3270LQT, LCPG1272, LCPG0973, 2AKN9Z0EM, LCPG0447, MXL4390NJC, LCPG0768, USC3250712, LCPG0626, 28KN9Z7039, US10570100, US13804158, US94800391, CZC5252BGI, LCPE0041, LCPF0128, LCPG0310, LCPG0432, FRB3270L25, LCPG0761, 51KN9ZE957, LCPG0524, US14110777, LCPG0418, US14110777, LCPG0418, LCPG1268, CZC5251GCB, US04552506, LCPF0165, LCPF0165, FRB3270G5Z, LCPG0942, 28KN9ZL0MV, USC3220T8R, LCPG1045, FRB3270LSD, LCPG0982, FRB3270LSD, LCPG0982, CZC52403GM, LCPG1033, 429000KH, LCPG0894, 70018555, 70018230, LCPG1226, CZC524038J, LCPG1042, LCPG1152, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, FRB32806ZY, LCPG0772, US14111131, LCPG0393, MXL4390NJB, LCPG0881, MXL4360D21, US14110727, SCZC52529XT, LCPG0306, FRB3270L1D, LCPG0842, 2UA43304Z2, LCPG0801, LCPG1292, LCPG1128, 2UB42002SG, CZC5252BHC, FRB32806D7, SVC1, LCPG0812, LCPG0930, LCPG0762, LCPG1306, 51KN9ZE943, LCPG0468, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0875, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0739, LCPG0740, LCPG0875, 2UB3370CRC, MXL4390NFJ, LCPG0769, LCPG0638, LCPG1036, CZC523187N, LCPG0294, MXL4360D1V, MXL4390NGT, USC326023Y, CZC5231FX5, CZC524035H, CZC5252B7K, CZC5252BOP, LCPG0572, LCPG0790, LCPG0791, LCPG1062, LCPG1162, LCPG1315, LCPG1318, FRB328070C, US14110905, CZC5240316, LCPG0396, LCPG1237, 2UB3370C62, LCPG0544, 29KN9ZP257, LCPG0537, US11303448, LCPG0252, FRB3270L0V, FRB3270L6P, LCPG0987, LCPG0932, FRB3270L1G, 2UA4020LMG, US04552507, LCPF0162, LCPF0162, LCPG0725, LCPG0725, 2UA431044W, CZC5257GHS, FRB32806CW, LCPG0411, LCPG0988, LCPG1037, 2UB3370CPR, US14111094, LCPG0399, LCPG0399, USU32703XT, 70018561, CZC5251GD5, CZC5252B76, LCPG0667, USC3220TSM, CZC5252BCV, LCPG0625, LCPG1069, 51KN9ZE964, LCPG0528, 2UB42002RV, LCPG0809, FRB3270LV3, LCPG0844, 2UB423087N, MXL4360CZS, USC325070H, 70018262, 70018263, 70018264, 70018558, 70018559, 70018560, LCPG0425, LCPG0634, LCPF0136, LCPF0136, LCPF0136, LCPG0265, LCPG0421, LCPG0421, LCPG0425, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0803, FRB328070L, LCPF0136, LCPG0265, LCPG0421, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0879, SCZC5252B5W, LCPG1321, LCPG1289, CZC5252BFR, LCPG00001289, 2UA4020483, LCPG0726, LCPG1032, CZC52403GH, LCPG1032, 429000KR, CZC5251G3L, CZC5251GSM, CZC5252B2Q, LCPG0893, LCPG1172, 28KN9ZX0T3, MXL4390NJ1, MXL4390NJ1, US04552482, US04552482, US13053013, US13053013, CZC5240314, CZC5252BCC, CZC525GZK, CZC525GZK, FRB3270L1V, FRB3270L1V, LCPF0173, LCPF0173, LCPG0293, LCPG0293, LCPG0376, LCPG0718, LCPG0718, LCPG0934, LCPG0934, LCPG1067, LCPG1067, LCPG1129, LCPG1129, LCPG1139, LCPG1139, LCPG1239, LCPG1239, LCPG1307, LCPG1307, LCPG1322, LCPG1324, LCPG1326, USW3190C0K, FRB3270L5V, LCPG0576, LCPG0971, 29KN9ZP1EE, LCPG0488, 51KN9ZE919, MXL4420B96, LCPG0895, FRB3270L0W, LCPG0864, CZC5252B9H, LCPG1282, 2UB3370B15, CZC52403GC, LCPG0730, LCPG1027, 2UA4020LFK, LCPG0641, FRB3270L09, LCPG0758, USC326023W, LCPG0631, 28KN9ZP0T0, LCPG0386, USU32703Y3, USU32703Y3, FRB3270LQR, FRB32806GB, LCPG0972, 2UB3370CQK, 2UB33803P7, CZC52529Z3, LCPG0669, FRB328072N, LCPG0891, MXL4420B9X, LCPG0901, 51KN9ZE929, LCPG0526, LCPG1288, 28KN9Z70VB, 2UB3370C1Z, 2UB3370CJZ, MXL4360D1N, MXL4390NGV, MXL4390NH1, MXL4390NJD, US14110846, LCPG0281, LCPG0373, LCPG0557, LCPG0566, LCPG0759, LCPG0767, FRB3270L4P, LCPG0985, FRB32806GD, FRB32806Y, LCPG1003, LCPG0783, CZC5252BGV, US04552498, LCPF0168, LCPF0168, FRB3270L12, LCPG0843, FRB3280732, LCPG0892, US04552474, US10570127, CZC52316, CZC5231GH5, LCPF0171, LCPF0130, CZC5251G1H, LCPG1253, LCPG0307, US94800162, LCPD0023, US03570619, LCPF0159, LCPG0786, US03910949, US13809040, LCPF0176, FRB3270KZL, LCPG0770, FRB328072F, LCPG0936, 2AKN9ZG01T, LCPG0440, US04552496, LCPF0169, MXL5040CBX, LCPG0680, MXL4390NHC, US14110747, LCPG0424, LCPG1113, LCPG0721, 2UA4020L7C, LCPG0540, US12754765, CZC5252BH3, 2UB3370C5S, LCPG0556, 2UB42002SF, LCPG0813, LCPG1312, 51KN9ZE925, 51KN9ZE971, LCPG0460, LCPG0467, 2UB33709QM, CZC5251GBX, LCPG0729, CZC5251H5V, SCZC52529X7, LCPG0302, CZC5231G6P, LCPG0616, LCPG1076, USC3260255, LCPG0616, LCPG1025, FRB328070R, LCPG0887, 2UA4020480, 2AKN9ZG011, 2AKN9ZG01E, LCPG0438, US14110776, US14111133, CZC52403G3, FRB3270L1Z, FRB328070H, LCPG0283, LCPG0300, 2UA4330426, MXL4360D0S, LCPG0793, 2UA4110GFC, 2UA4110GFB, LCPG0814, LCPG0299, US14110937, LCPG0420, US13804192, US14110820, LCPG1285, US14110820, USW3190C0R, LCPG0615, 2UA4020LMD, FRB3270LRT, LCPG0722, LCPG0975, US11303388, US11303620, US14014730, LCPG0251, LCPG0254, LCPG0423, 29KN9ZP1BP, LCPG0493, US14110994, SCZC5252B61, 28KN9Z70EX, LCPG0397, LCPG0383, US14110995, LCPG0232, USU32703VY, LCPG0571, US13804183, LCPG0295, 2UB3370C67, 2UB3370CR0, LCPG0677, LCPG0688, CZC52402Q4, LCPG1171, US14110928, LCPG0416, 2UA402048M, LCPG0715, US14014714, LCPG0241, US14014501, LCPG0243, 29KN9ZP1E8, LCPG0446, SCZC5252B4N, CZC5251GZH, FRB32806F8, LCPG0959, 29KN9ZP1TM, 2UA433044P, 2UB3370C5B, LCPG0495, LCPG0555, LCPG0787, US14111137, LCPG1310, LCPG0412, CZC5252BDW, LCPG0763, 2UA4220137, LCPG0763, 28KN9ZP0RJ, USU32703YD, LCPG0388, LCPG0665, LCPG1313, 2UA4020LB0, LCPG0705, USC2340J87, 29KN9ZP24L, CZC5252BHF, LCPG1107, CZC52402QY, LCPG0445, US03910979, LCPF0177, US14110854, LCPG0308, US11302407, LCPG0253, US13804157, CZC524030N, LCPG0301, 2UB33803QK, LCPG0437, FRB3270L1Q, LCPG0933, FRB3280727, LCPG1043, CZC524030P, CZC5240311, LCPG1174, LCPG1175, CZC52402QM, LCPG1244, LCPG1286, USW3190C09, LCPG0612, 2UB3370C6S, LCPG0558, MXL51603JZ, LCPG0962, FRB3270L08, LCPG0878, 2UB33706CW, LCPG0653, 2UB3370CR1, LCPG0687, 2UB3370C33, LCPG0543, 2UB3370CQ1, LCPG0685, MXL4360D1R, CZC2403GK, LCPG1026, LCPG0820, CZC524035C, FRB3280720, LCPG1110, SCZC52529Y6, SCZC5252B3T, LCPG0889, LCPG1319, LCPG1320, 29KN9ZP1ED, LCPG0533, US10570124, LCPF0129, 2UA431043K, LCPG0818, FRB3270L3X, LCPG0984, CZC52402PT, LCPG1164, FRB3270LL9, LCPG0951, MXL4390NHR, LCPG0771, MXL5040CC0, LCPG0968, FRB3270HKQ, LCPG0953, MXL4360D1L, LCPG0827, 2UA422011R, 2UA422088D, 2UA423087T, MXL4360D1Z, CZC5252BKP, CZC5252BL5, LCPD0019, LCPG0678, LCPG0802, LCPG0678, LCPG0802, LCPG0804, LCPG0678, LCPG0802, LCPG0804, CZC52403GP, LCPG1034, FRB32806DV, LCPG0989, US03570598, LCPF0158, CZC52403G2, LCPG1051, CZC5231FX1, CZC5252B9K, LCPG1061, 28KN9Z70SB, CZC5252BLC, LCPG1092, CZC524032R, LCPG1109, 2CKN9ZM19L, LCPG0534, CZC5252B7T, LCPG1166, USC3260246, LCPG0614, LCPG0553, CZC5252BBP, LCPG0405, FRB328072L, LCPG0681, 28KN9ZP1F5, LCPG0385, MXL5100795, CZC5251G63, LCPG1205, US14110830, FRB3270HJK, FRB3270LQ3, LCPG0417, 70018261, LCPG1228, 2UA433040P, LCPG0795, 28KN9ZL17N, LCPG0410, 2UA433032P, LCPG0764, CZC5231GHO, LCPG1073, CZC5252BJ3, LCPG0401, US13809118, LCPG0311, US04552493, LCPF0180, US94362911, LCPD0022, FRB32806F9, LCPG1000, USU32703XC, CZC52403GL, SU94362917, US03908709, LCPF0157, CZC524031G, US14110926, LCPG0415, LCPG1311, 51KN9ZE953, LCPG0456, CZC5251GW5, LCPG1046, 2UA4020LBG, LCPG0565, CZC5231FWZ, LCPG1056, 2AKN9ZG00B, LCPG0381, LCPG0381, 2UA4020LB3, CZC52402XX, LCPG1165, 2AKN9ZG00V, LCPG0434, SCZC5252B4G, 29KN9ZP1V5, LCPG0494, FRB32806FH, LCPG-0990, US03570644, LCPF0138, US14111089, US14111116, LCPG0309, CZC5251G2B, LCPG1072, FRB3270L84, LCPG0960, 2UA4110GFR, LCPG0784, LCPG1273, CZC524030F, PULLED, US14110814, LCPG0321, US14111141, LCPG0404, CZC525BQ5, 2AKN9ZF29B, LCPG0382, 2UA412034M, LCPG0785, LCPG0785, SCZC5252BD4, 2UA43104, LCPG0765, CZC5251GPH, LCPG1054, US14110879, LCPG00428, 28KN9ZL0DX, 28KN9ZL01J, LCPG0406, 2UB42002RY, CZC5251GDT, CZC5251GQH, FRB3270LQV, SCZC5252BOT, LCPG0810, LCPG0974, LCPG1090, LCPG1130, 28KN9ZL0HH, 28KN9ZL164, 2CKN9ZM11V, 2CKN9ZM19H, 2CKN9ZM1LV, 2CKN9ZV1M0, 2UA422010N, 2UB42002S4, US11303368, US11856174, US13813372, US94800510, CZC5240305, CZC5251GHN, LCPD0018, LCPG0255, LCPG0290, LCPG0387, LCPG0394, LCPG0403, LCPG0529, LCPG0530, LCPG0568, LCPG0569, LCPG0806, LCPG0811, LCPG0296, US13804095, US10570024, LCPF0126, 2UB42002SC, LCPG0815, LCPG0535, FRB3270KDV, LCPG0969, USW3190C0S, LCPG0623, US14111088, LCPG0298, FRB3270L6B, LCPG0986, CZC52402Y6, CZC5251GQF, LCPG0430, MXL5310FQK, CZC5252B4N, 28KN9ZN0H7, LCPG0584, 2CKN9ZV1M7, 2CKN9ZV1M7, LCPG0575, LCPG0575, LCPG0808, LCPG0828, 28KN9ZL027, LCPG0408, 2UA4330438, LCPG0766, CZC5252BHQ, LCPG1098, CZC5252BF7, LCPG1275, LCPG0491, 2UA42200Z1, LCPG0496, 28KN9ZL0PZ, 2UA41106JL, US94800373, CZC5231FWQ, CZC5251H0Z, CZC5252BJP, FRB3270LRH, FRB32806FY, 90314720(LCPG0310), LCP-E0042, LCPG-0297, LCPG0250, LCPG0384, LCPG0392, LCPG0405, LCPG0414, LCPG0422, LCPG0531, LCPG0564, LCPG1163 and LCPG1213.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution; including the islands of Puerto Rico and Hawaii.

MagNA Pure LC 1.0 (software version 3.0.11). || Roche Diagnostics Operations, Inc. || An automated instrument used for 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 the making of dilution series, reaction mixes.

Series 2.0 software version 1.1.23 and 1.1.24, Part number 05197686001, Ser Numbers LC2C00000383, LC2C00000566, LC2C00000572, LC2C00000428, LC2C00000482, LC2C00000266, LC2C00000192, LC2C00000216, LC2C00000233, LC2C00000419, LC2C00000531, LC2C00000033, LC2C00000583, LC2C00000127, LC2C00000170, LC2C00000563, LC2C00000234, LC2C00000561, LC2C00000205, LC2C00000394, LC2C00000329, LC2C00000418, LC2C00000420, LC2C00000569, LC2C00000570, LC2C00000564, LC2C00000486, LC2C00000483, LC2C00000158, LC2C00000214, LC2C00000215, LC2C00000265, LC2C00000309, LC2C00000217, LC2C00000254, LC2C00000081, LC2C00000159, LC2C00000212, LC2C00000213, LC2C00000293, LC2C00000427, LC2C00000232, LC2C00000242, LC2C00000134, LC2C00000168, LC2C00000219, LC2C00000479, LC2C00000228, LC2C00000580, LC2C00000243, LC2C00000263, LC2C00000393, LC2C00000155, LC2C00000203, LC2C00000204, LC2C00000267, LC2C00000268, LC2C00000193, LC2C00000206, LC2C00000381, LC2C00000381, LC2C00000429, LC2C00000588, LC2C00000449, LC2C00000218, LC2C00000253, LC2C00000110, LC2C00000156, LC2C00000128, LC2C00000162, LC2C00000178, LC2C00000118, LC2C00000079, LC2C00000273, LC2C00000431, LC2C00000477, LC2C00000196, LC2C00000130, LC2C00000310, LC2C00000264, LC2C00000414, LC2C00000276, LC2C00000312, LC2C00000313, LC2C00000361, LC2C00000363, LC2C00000331, LC2C00000330, LC2C00000236, LC2C00000360, LC2C00000294, LC2C00000298, LC2C00000532, LC2C00000220, LC2C00000270, LC2C00000413, LC2C00000120, LC2C00000274, LC2C00000227, LC2C00000384, LC2C00000275, LC2C00000364, LC2C00000269, LC2C00000252, LC2C00000119, LC2C00000250, LC2C00000235, LC2C00000169, LC2C00000244, LC2C00000108, LC2C00000256, LC2C00000272, LC2C00000173, LC2C00000582, LC2C00000064, LC2C00000255, LC2C00000179, LC2C00000562, LC2C00000581, LC2C00000035, LC2C00000080, LC2C00000172, LC2C00000412, LC2C00000032, LC2C00000131, LC2C00000195, LC2B00000042, LC2C00000039, LC2C00000043, LC2C00000034, LC2C00000132, LC2C00000133, LC2C00000060, LC2C00000180, LC2C00000578, LC2C00000314, LC2C00000571, 2C00000565, LC2C00000415, LC2C00000430, LC00000529, LC2C00000044, LC2C00000129, LC2C00000297, LC2C00000358, LC2C00000359, LC2C00000392 and LC2C00000434.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution; including the islands of Puerto Rico and Hawaii.

MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) || Roche Diagnostics Operations, Inc. || An automated instrument used for 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 the making of dilution series, reaction mixes.

Elecsys 2010 Analyzer Rack: 11804014001 Elecsys 2010 Analyzer Disk: 11568248001 Software version 06-07: 06526080001, 06569668001

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA including NY, GA, DE, SD, WI, ME, OR, IA, AND CA and the countries of Austria, Cyprus, Czech Republic, Estonia, France, Germany,Greece, Hungary, Iceland, Italy, Latvia, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Switzerland

Elecsys 2010 Analyzer Software version 06-07 || The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.