| COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 (P060030/S044) | Roche Molecular Systems, Inc. | 2015-01-14 |
| COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S051) | Roche Molecular Systems, Inc. | 2015-01-14 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S043) | Roche Molecular Systems, Inc. | 2015-01-14 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S017) | Roche Molecular Systems, Inc. | 2015-01-14 |
| ARCHITECT AUSAB PMA ASSAY (P050051/S029) | Abbott Laboratories, Inc. | 2014-12-30 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY PMA ASSAYS (P110029/S020) | Abbott Laboratories | 2014-12-30 |
| ELECSYS HBSAG CONFIRMATORY TEST (P990012/S022) | Roche Diagnostics Corp. | 2014-12-22 |
| ELECSYS ANTI-HBS CALCHECK (P010054/S024) | Roche Diagnostics Corp. | 2014-12-22 |
| ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S019) | Abbott Laboratories | 2014-12-17 |
| ARCHITECT AUSAB (P050051/S028) | Abbott Laboratories, Inc. | 2014-12-11 |
| VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS (P000014/S028) | Ortho-Clinical Diagnostics, Inc. | 2014-12-11 |
| ARCHITECT CORE (P080023/S026) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT HBSAG QUALITATIVE (P110029/S018) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT ANTI-HCV (P050042/S031) | Abbott Laboratories, Inc. | 2014-12-11 |
| ARCHITECT CORE-M (P060035/S024) | Abbott Laboratories | 2014-12-11 |
| ABBOTT REALTIME HCV ASSAY (P100017/S011) | Abbott Molecular, Inc. | 2014-12-10 |
| ABBOTT REALTIME HVB ASSAY (P080026/S013) | Abbott Molecular, Inc. | 2014-12-10 |
| QUANTIFERON-TB GOLD TEST (P010033/S026) | Qiagen | 2014-12-10 |
| REALTIME HCV GENOTYPE II (P120012/S006) | Abbott Molecular | 2014-12-10 |
| QUANTIFERON- TB GOLD TEST (P010033/S025) | Qiagen | 2014-12-04 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0, COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S050) | Roche Molecular Systems, Inc. | 2014-12-04 |
| ELECSYS HBEAG ON MODULAR ANALYTICS E170 (P130015/S002) | Roche Diagnostics Operations, Inc. | 2014-11-26 |
| ELECSYS ANTI-HBC ON COBAS E 601 (P100031/S012) | Roche Diagnostics Corp. | 2014-11-26 |
| ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P120012/S005) | Abbott Molecular | 2014-11-20 |
| ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P100017/S010) | Abbott Molecular, Inc. | 2014-11-20 |
| ABBOTT REALTIME HBV ASSAY (P080026/S012) | Abbott Molecular, Inc. | 2014-11-20 |
| IMMULITE HBSAG, IMMULITE 2000 HBSAG (P010050/S016) | Siemens Healthcare Diagnostics Products, Ltd. | 2014-11-18 |
| ARCHITECT AUSAB (LN 1L82) (P050051/S027) | Abbott Laboratories, Inc. | 2014-10-29 |
| ADVIA CENTAUR HBSAG (HBS) ASSAY (P030049/S011) | Siemens Healthcare Diagnostics | 2014-10-28 |
| ARCHITECT CORE (LN 6L22) (P080023/S025) | Abbott Laboratories | 2014-10-16 |
| ARCHITECT ANTI-HCV (LN IL79) (P050042/S030) | Abbott Laboratories, Inc. | 2014-10-16 |
| ARCHITECT CORE-M (LN 6L23) (P060035/S023) | Abbott Laboratories | 2014-10-16 |
| DIGENE HC2 SYSTEM SOFTWARE (P890064/S031) | Qiagen Gaithersburg, Inc. | 2014-10-09 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S018) | OraSure Technologies, Inc. | 2014-10-02 |
| ABBOTT REAL TIME HCV GENOTYPE II (P120012/S004) | Abbott Molecular | 2014-09-25 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S012) | Roche Diagnostics Corp. | 2014-09-19 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602 (P090008/S014) | Roche Diagnostics Corp. | 2014-09-19 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 170 (P090009/S012) | Roche Diagnostics Corp. | 2014-09-19 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S017) | OraSure Technologies, Inc. | 2014-09-02 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S043) | Roche Molecular Systems, Inc. | 2014-08-22 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S016) | OraSure Technologies, Inc. | 2014-07-11 |
| APTIMA HPV ASSAY (P100042/S003) | Gen-Probe Incorporated | 2014-07-07 |
| ETI-MAK-2 PLUS ASSAY (P990038/S020) | DiaSorin, Inc. | 2014-06-27 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S017) | DiaSorin, Inc. | 2014-06-27 |
| ETI-EBK PLUS ASSAY (P990043/S020) | DiaSorin, Inc. | 2014-06-27 |
| ETI-AB-COREK PLUS ASSAY (P990045/S017) | DiaSorin, Inc. | 2014-06-27 |
| ETI-AB-AUK-PLUS (P990042/S016) | DiaSorin, Inc. | 2014-06-27 |
| ETI-AB-EBK PLUS ASSAY (P990041/S019) | DiaSorin, Inc. | 2014-06-27 |
| ELECSYS ANTI-HBC (P100031/S011) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS ANTI-HBS (P010054/S023) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS HBS AG (P990012/S021) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS ANTI-HCV (P090008/S013) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG (P130015/S001) | Roche Diagnostics Operations, Inc. | 2014-06-06 |
| ARTUS CMV RGQ MDX KIT (P130027) | Qiagen, Inc. | 2014-06-02 |
| QUANTIFERON TB GOLD IN-TUBE (P010033/S024) | Qiagen | 2014-05-22 |
| ADVIA CENTAUR HBSAGII (P110041) | Siemens Corp. | 2014-05-16 |
| DIGENE HC2 STSTEM SOFTWARE (P890064/S030) | Qiagen Gaithersburg, Inc. | 2014-05-12 |
| CERVISTA HPV HR AND GENFIND KIT (P080014/S018) | Hologic, Inc. | 2014-04-29 |
| APTIMA HPV ASSAY (P100042/S002) | Gen-Probe Incorporated | 2014-04-29 |
| APTIMA HPV 16 18/45 GENETYPE ASSAY (P120007/S002) | Gen-Probe Incorporated | 2014-04-29 |
| CERVISTA HPV 16/18 (P080015/S009) | Hologic, Inc. | 2014-04-29 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S042) | Roche Molecular Systems, Inc. | 2014-04-28 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S042) | Roche Molecular Systems, Inc. | 2014-04-28 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S049) | Roche Molecular Systems, Inc. | 2014-04-28 |
| COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST (P110037/S015) | Roche Molecular Systems, Inc. | 2014-04-28 |
| ARCHITECT ANTI-HCV (P050042/S029) | Abbott Laboratories, Inc. | 2014-04-28 |
| COBAS HPV TEST (P100020/S008) | Roche Molecular Systems, Inc. | 2014-04-24 |
| BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) (P100025/S005) | Meridian Bioscience, Inc. | 2014-04-18 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S017) | Abbott Laboratories | 2014-04-15 |
| ARCHITECT AUSAB (P050051/S026) | Abbott Laboratories, Inc. | 2014-04-15 |
| DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 HPV DNA TEST (P890064/S029) | Qiagen Gaithersburg, Inc. | 2014-04-14 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S041) | Roche Molecular Systems, Inc. | 2014-04-04 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S041) | Roche Molecular Systems, Inc. | 2014-04-04 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S048) | Roche Molecular Systems, Inc. | 2014-04-04 |
| COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST (P110037/S014) | Roche Molecular Systems, Inc. | 2014-04-04 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S020) | Roche Diagnostics Corp. | 2014-03-21 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S022) | Roche Diagnostics Corp. | 2014-03-21 |
| ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S009) | Roche Diagnostics Corp. | 2014-03-21 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| COMBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S040) | Roche Molecular Systems, Inc. | 2014-03-18 |
| COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0 (P060030/S040) | Roche Molecular Systems, Inc. | 2014-03-18 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S013) | Roche Molecular Systems, Inc. | 2014-03-18 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015) | Roche Diagnostics Operations, Inc. | 2014-03-14 |
| ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS (P000014/S027) | Ortho-Clinical Diagnostics, Inc. | 2014-03-10 |
| CERVISTA HPV HR TEST (P080014/S019) | Hologic, Inc. | 2014-03-04 |
| COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 (P060030/S039) | Roche Molecular Systems, Inc. | 2014-03-04 |
| CERVISTA HPV 16/18 TEST (P080015/S010) | Hologic, Inc. | 2014-03-04 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) (P100025/S006) | Meridian Bioscience, Inc. | 2014-02-19 |
| QUANTIFERON -TB GOLD (P010033/S023) | Qiagen | 2014-01-31 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0,COBAS AMPLIPREP/COBAS TAQMAN WASH REAGENT (P050028/S039) | Roche Molecular Systems, Inc. | 2014-01-23 |
| ETI-AB-EBK PLUS ASSAY (P990041/S018) | DiaSorin, Inc. | 2014-01-10 |
| ETI-AB-AUK PLUS ASSAY (P990042/S015) | DiaSorin, Inc. | 2014-01-10 |
| ETI-CORE-IGMK PLUS (P990044/S016) | DiaSorin, Inc. | 2014-01-10 |
| ETI-MAK-2 PLUS ASSAY (P990038/S019) | DiaSorin, Inc. | 2014-01-10 |
| ETI-EBK PLUS (P990043/S019) | DiaSorin, Inc. | 2014-01-10 |
| ETI-AB-COREK PLUS ASSAY (P990045/S016) | DiaSorin, Inc. | 2014-01-10 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST (P050028/S038) | Roche Molecular Systems, Inc. | 2014-01-09 |
| COBAS AMPLICOR HCV TEST V2.0 (P000012/S047) | Roche Molecular Systems, Inc. | 2014-01-09 |
| ARCHITECT AUSAB ASSAY (P050051/S025) | Abbott Laboratories, Inc. | 2014-01-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S038) | Roche Molecular Systems, Inc. | 2014-01-09 |