| ARCHITECT CORE (P080023/S014) | Abbott Laboratories | 2012-04-13 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029) | Abbott Laboratories | 2012-04-12 |
| ELECSYS HBSAG (P990012/S014) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170 (P100031/S006) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HBS (P010054/S019) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HCV ON COBAS E 601 (P090008/S009) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170 (P090009/S008) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HBC ON ELECSYS 2010 (P100032/S006) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HCV ON COBAS E 411 (P090007/S008) | Roche Diagnostics Corp. | 2012-03-28 |
| HBSAG IMMULITE SUBSTRATE REAGENT (P010050/S015) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| ANTI-HBS IMMULITE SUBSTRATE REAGENT (P010052/S011) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| ANTI-HBCM IMMULITE SUBSTRATE REAGENT (P010053/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| ANTI-HBC IMMULITE SUBSTRATE REAGENT (P010051/S011) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| ROCHE COBAS TAQMAN HBV TESTS (P050028/S020) | Roche Molecular Systems, Inc. | 2012-03-20 |
| COBAS TAQMAN HCV TESTS (P060030/S021) | Roche Molecular Systems, Inc. | 2012-03-20 |
| ELECSYS HBSAG (HBSAG) TEST SYSTEM (P990012/S012) | Roche Diagnostics Corp. | 2012-03-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR (P000014/S025) | Ortho-Clinical Diagnostics, Inc. | 2012-03-13 |
| ETI-MAK-2 PLUS ASSAY (P990038/S015) | DiaSorin, Inc. | 2012-03-09 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S012) | DiaSorin, Inc. | 2012-03-09 |
| ETI-EBK-PLUS (P990043/S015) | DiaSorin, Inc. | 2012-03-09 |
| ETI-AB-EBK PLUS ASSAY (P990041/S014) | DiaSorin, Inc. | 2012-03-09 |
| ETI-AB-AUK PLUS ASSAY (P990042/S011) | DiaSorin, Inc. | 2012-03-09 |
| ETI-AB-COREK PLUS ASSAY (P990045/S012) | DiaSorin, Inc. | 2012-03-09 |
| ARCHITECT CORE (P080023/S011) | Abbott Laboratories | 2012-03-02 |
| ARCHITECT CORE-M (P060035/S011) | Abbott Laboratories | 2012-03-02 |
| AXSYM HBSAG (P050049/S010) | Abbott Laboratories, Inc. | 2012-03-01 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S029) | Ortho-Clinical Diagnostics, Inc. | 2012-02-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR (P030026/S025) | Ortho-Clinical Diagnostics, Inc. | 2012-02-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S022) | Ortho-Clinical Diagnostics, Inc. | 2012-02-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S018) | Ortho-Clinical Diagnostics | 2012-02-23 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 (P100025) | Meridian Bioscience, Inc. | 2012-02-22 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S008) | Siemens Healthcare Diagnostics | 2012-02-03 |
| ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL (P100039) | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR) (P080014/S010) | Hologic, Inc. | 2012-01-20 |
| ABBOTT ARCHITECT HBSAG & HBSAG CONFIRMATORY (P060007/S017) | Abbott Laboratories | 2012-01-13 |
| COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.0 (P000012/S033) | Roche Molecular Systems, Inc. | 2012-01-11 |
| AMPLICOR HCV TEST (P000010/S024) | Roche Molecular Systems, Inc. | 2012-01-11 |
| T-SPOT .TB TEST (P070006/S006) | Oxford Immunotec, Ltd. | 2012-01-04 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031) | Roche Diagnostics Corp. | 2012-01-03 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST (P050028/S019) | Roche Molecular Systems, Inc. | 2011-12-29 |
| COBAS AMPLICOR HCV TEST, V2.0 (P000012/S031) | Roche Molecular Systems, Inc. | 2011-12-29 |
| COBAS HPV TEST (P100020/S001) | Roche Molecular Systems, Inc. | 2011-12-29 |
| AMPLICOR HCV TEST V2.0 (P000010/S022) | Roche Molecular Systems, Inc. | 2011-12-29 |
| BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S012) | Diasorin | 2011-12-29 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST (P060030/S020) | Roche Molecular Systems, Inc. | 2011-12-29 |
| AXSYM AUSAB (LN 3C74) (P060003/S011) | Abbott Laboratories, Inc. | 2011-12-22 |
| AXSYM CORE 2.0 (LN 8B88) (P060012/S009) | Abbott Laboratories, Inc. | 2011-12-22 |
| AXSYM CORE-M 2.0 (LN 3B89) (P060009/S006) | Abbott Laboratories, Inc. | 2011-12-22 |
| AXSYM HBSAG/CONFIRMATORY (LN 9B01) (P050049/S009) | Abbott Laboratories, Inc. | 2011-12-22 |
| AXSYM ANTI-HCV (LN 5C36) (P970027/S017) | Abbott Laboratories | 2011-12-22 |
| ARCHITECT CORE (P080023/S012) | Abbott Laboratories | 2011-12-21 |
| ARCHITECT AUSAB (P050051/S014) | Abbott Laboratories, Inc. | 2011-12-21 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S016) | Abbott Laboratories | 2011-12-21 |
| ARCHITECT CORE-M (P060035/S013) | Abbott Laboratories | 2011-12-21 |
| ACHITECT ANTI-HCV (P050042/S015) | Abbott Laboratories, Inc. | 2011-12-21 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA (P110025) | Roche Diagnostics Corp. | 2011-12-14 |
| ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 601 (P090008/S007) | Roche Diagnostics Corp. | 2011-12-14 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS (P090009/S006) | Roche Diagnostics Corp. | 2011-12-14 |
| ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411 (P090007/S006) | Roche Diagnostics Corp. | 2011-12-14 |
| CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION (P080014/S007) | Hologic, Inc. | 2011-12-12 |
| ARCHITECT ANTI-HCV (P050042/S014) | Abbott Laboratories, Inc. | 2011-12-01 |
| ARCHITECT CORE-M (P060035/S012) | Abbott Laboratories | 2011-12-01 |
| ARCHITECT CORE (P080023/S010) | Abbott Laboratories | 2011-12-01 |
| ABBOTT REALTIME HBV ASSAY (P080026/S002) | Abbott Molecular, Inc. | 2011-11-30 |
| ABBOTT REALTIME HCV ASSAY (P100017/S001) | Abbott Molecular, Inc. | 2011-11-30 |
| T-SPOT TB TEST (P070006/S007) | Oxford Immunotec, Ltd. | 2011-11-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170 (P090009/S005) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S005) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S016) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010 (P100032/S004) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170 (P100031/S004) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S011) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 (P090008/S005) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S010) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S004) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010 (P100032/S002) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170 (P100031/S002) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E170 (P090009/S004) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 601 (P090008/S004) | Roche Diagnostics Corp. | 2011-11-16 |
| ETI-AB-AUK PLUS KIT (P990042/S010) | DiaSorin, Inc. | 2011-11-15 |
| ETI-AB-COREK PLUS KIT (P990045/S011) | DiaSorin, Inc. | 2011-11-15 |
| ETI-AB-EBK PLUS KIT (P990041/S013) | DiaSorin, Inc. | 2011-11-15 |
| ETI-MAK-2 PLUS KIT (P990038/S014) | DiaSorin, Inc. | 2011-11-15 |
| ETI-CORE-IGMK PLUS KIT (P990044/S011) | DiaSorin, Inc. | 2011-11-15 |
| ABBOTT AXSYM HBSAG (P050049/S008) | Abbott Laboratories, Inc. | 2011-11-14 |
| VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY (P010021/S021) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY (P030026/S024) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY (P000014/S024) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY (P030024/S017) | Ortho-Clinical Diagnostics | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG ASSAY AND HBSAG CONFIRMATORY KIT (P000044/S028) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| APTIMA HPV ASSAY (P100042) | Gen-Probe Incorporated | 2011-10-28 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022) | Roche Diagnostics Corp. | 2011-10-26 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK & CALIBRATOR (P090028/S001) | Ortho-Clinical Diagnostics, Inc. | 2011-10-21 |
| ORAQUICK RAPID HCV ANTIBODY (P080027/S003) | OraSure Technologies, Inc. | 2011-10-20 |
| QUANTIFERON -TB GOLD (P010033/S019) | Qiagen | 2011-10-20 |
| AXSYM ANTI-HCV (P970027/S016) | Abbott Laboratories | 2011-10-19 |
| AMPLICOR HCV TEST V2.0 & COBAS AMPLICOR HCV TEST V2.0 (P000010/S025) | Roche Molecular Systems, Inc. | 2011-10-11 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S023) | Roche Molecular Systems, Inc. | 2011-10-11 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S022) | Roche Molecular Systems, Inc. | 2011-10-11 |
| ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL (P090024) | Siemens Healthcare Diagnostics | 2011-10-11 |