| ELECSYS ANTI-HCV TEST SYSTEM (P090009/S014) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HBS TEST SYSTEM (P010054/S027) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HCV TEST SYSTEM (P090008/S016) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HCV TEST SYSTEM (P090007/S014) | Roche Diagnostics Corp. | 2016-02-24 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S022) | OraSure Technologies, Inc. | 2016-02-20 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S048) | Roche Molecular Systems, Inc. | 2016-02-18 |
| COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 (P060030/S049) | Roche Molecular Systems, Inc. | 2016-02-09 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S024) | Roche Molecular Systems, Inc. | 2016-02-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S048) | Roche Molecular Systems, Inc. | 2016-02-09 |
| BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA (P100025/S010) | Meridian Bioscience, Inc. | 2016-01-27 |
| VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO (P000014/S029) | Ortho-Clinical Diagnostics, Inc. | 2015-12-16 |
| HOME ACCESS HEPATITIS C CHECK (P980046/S009) | Pwn Health Chicago, LLC | 2015-12-09 |
| ELECSYS ANTI-HCV (P090008/S015) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HBC (P100032/S010) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HCV (P090009/S013) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HCV II (P140021/S001) | Roche Diagnostics Operations, Inc. | 2015-11-24 |
| ELECSYS ANTI-HBS (P010054/S025) | Roche Diagnostics Corp. | 2015-11-24 |
| APTIMA HPV ASSAY (P100042/S007) | Gen-Probe Incorporated | 2015-11-24 |
| ELECSYS HBEAG (P130015/S004) | Roche Diagnostics Operations, Inc. | 2015-11-24 |
| ELECSYS ANTI-HBC (P100031/S013) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HCV (P090007/S013) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS HBSAG (P990012/S023) | Roche Diagnostics Corp. | 2015-11-24 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) (P100025/S009) | Meridian Bioscience, Inc. | 2015-11-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR (P000044/S033) | Ortho-Clinical Diagnostics, Inc. | 2015-11-20 |
| APTIMA HPV ASSAY (P100042/S009) | Gen-Probe Incorporated | 2015-11-09 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S007) | Gen-Probe Incorporated | 2015-11-09 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR (P030026/S031) | Ortho-Clinical Diagnostics, Inc. | 2015-11-03 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S021) | OraSure Technologies, Inc. | 2015-10-15 |
| COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S054) | Roche Molecular Systems, Inc. | 2015-10-15 |
| COBAS HCV TEST (P150015) | Roche Molecular Systems, Inc. | 2015-10-14 |
| COBAS HBV TEST (P150014) | Roche Molecular Systems, Inc. | 2015-10-14 |
| ABBOTT REALTIME HCV (P100017/S014) | Abbott Molecular, Inc. | 2015-10-09 |
| ABBOTT REALTIME HBV (P080026/S016) | Abbott Molecular, Inc. | 2015-10-09 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S009) | Abbott Molecular | 2015-10-09 |
| VITROS HBEAG ASSAY (P090028/S009) | Ortho-Clinical Diagnostics, Inc. | 2015-09-08 |
| VITROS ANTI-HBS ASSAY (P000014/S031) | Ortho-Clinical Diagnostics, Inc. | 2015-09-08 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S023) | Ortho-Clinical Diagnostics | 2015-09-08 |
| VITROS ANTI-HBC IGM ASSAY (P030026/S030) | Ortho-Clinical Diagnostics, Inc. | 2015-09-08 |
| VITROS ANTI-HBE ASSAY (P100001/S008) | Ortho-Clinical Diagnostics | 2015-09-08 |
| VITROS HBSAG ASSAY (P000044/S032) | Ortho-Clinical Diagnostics, Inc. | 2015-09-08 |
| VITROS ANTI-HCV ASSAY (P010021/S027) | Ortho-Clinical Diagnostics, Inc. | 2015-09-08 |
| ARCHITECT AUSAB (LN 1L82) (P050051/S030) | Abbott Laboratories, Inc. | 2015-08-13 |
| ARCHITECT CORE-M (LN 6L23) (P060035/S025) | Abbott Laboratories | 2015-08-13 |
| ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) (P110029/S022) | Abbott Laboratories | 2015-08-13 |
| ARCHITECT ANTI-HCV (LN 1L79) (P050042/S032) | Abbott Laboratories, Inc. | 2015-08-13 |
| ARCHITECT CORE (LN 6L22) (P080023/S027) | Abbott Laboratories | 2015-08-13 |
| ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG (P130015/S003) | Roche Diagnostics Operations, Inc. | 2015-07-28 |
| IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS (P010052/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2015-07-27 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S022) | Roche Molecular Systems, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S008) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S022) | Ortho-Clinical Diagnostics | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S026) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S007) | Ortho-Clinical Diagnostics | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S030) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| COBAS TAQMAN HBV TEST, HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT (P050028/S047) | Roche Molecular Systems, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S031) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| COBAS HPC TEST,240 TESTS AND COBAS HPV TEST, 960 TESTS (P100020/S015) | Roche Molecular Systems, Inc. | 2015-07-23 |
| ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS (P110029/S021) | Abbott Laboratories | 2015-07-13 |
| ADVIA CENTAUR HCV ASSAY (P030056/S010) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ADVIA CENTAUR HBC IGM ASSAY (P030040/S010) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY (P100039/S003) | Siemens Healthcare Diagnostics, Inc. | 2015-07-10 |
| ADVIA CENTAUR HBSAGII ASSAY (P110041/S002) | Siemens Corp. | 2015-07-10 |
| ADVIA CENTAUR HBEAG ASSAY (P090024/S002) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ADVIA CENTAUR HBSAG ASSAY (P030049/S012) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S011) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ARTUS CMV RGQ MDX KIT (P130027/S001) | Qiagen, Inc. | 2015-07-09 |
| ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV (P140021) | Roche Diagnostics Operations, Inc. | 2015-06-11 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S003) | Gen-Probe Incorporated | 2015-06-05 |
| APTIMA HPV ASSAY (P100042/S004) | Gen-Probe Incorporated | 2015-06-05 |
| CERVISTA HPV 16/18 ASSAY (P080015/S012) | Hologic, Inc. | 2015-05-29 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS (P890064/S032) | Qiagen Gaithersburg, Inc. | 2015-05-29 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S021) | Roche Molecular Systems, Inc. | 2015-05-08 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S046) | Roche Molecular Systems, Inc. | 2015-05-08 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S047) | Roche Molecular Systems, Inc. | 2015-05-08 |
| APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S008) | Gen-Probe | 2015-05-08 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S045) | Roche Molecular Systems, Inc. | 2015-05-01 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S019) | Roche Molecular Systems, Inc. | 2015-05-01 |
| COBAS HPV TEST (P100020/S013) | Roche Molecular Systems, Inc. | 2015-05-01 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S044) | Roche Molecular Systems, Inc. | 2015-05-01 |
| REALTIME HCV GENOTYPE II (P120012/S007) | Abbott Molecular | 2015-04-23 |
| ABBOTT REALTIME HBV ASSAY (P080026/S014) | Abbott Molecular, Inc. | 2015-04-23 |
| ABBOTT REALTIME HCV ASSAY (P100017/S012) | Abbott Molecular, Inc. | 2015-04-23 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, CONAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S045) | Roche Molecular Systems, Inc. | 2015-04-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST,V2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S046) | Roche Molecular Systems, Inc. | 2015-04-09 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S020) | Roche Molecular Systems, Inc. | 2015-04-09 |
| COBAS HPV TEST (P100020/S014) | Roche Molecular Systems, Inc. | 2015-04-09 |
| COBAS AMPLICOR HCV TEST , VERSION 2.0 (P000012/S053) | Roche Molecular Systems, Inc. | 2015-04-09 |
| APTIMA HPV ASSAY (P100042/S005) | Gen-Probe Incorporated | 2015-04-01 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S004) | Gen-Probe Incorporated | 2015-04-01 |
| COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST (P110037/S016) | Roche Molecular Systems, Inc. | 2015-03-26 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR (P010021/S025) | Ortho-Clinical Diagnostics, Inc. | 2015-03-11 |
| ADVIA CENTAUR HCV READYPACKS (P030056/S008) | Siemens Healthcare Diagnostics | 2015-03-10 |
| BREATHTEK UBT FOR H.PYLORI KIT (P100025/S008) | Meridian Bioscience, Inc. | 2015-03-05 |
| ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL (P040004/S010) | Siemens Healthcare Diagnostics | 2015-02-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S029) | Ortho-Clinical Diagnostics, Inc. | 2015-02-12 |
| BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA) (P100025/S007) | Meridian Bioscience, Inc. | 2015-02-03 |
| ADVIA CENTAUR HBSAGII ASSAY (P110041/S001) | Siemens Corp. | 2015-02-02 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S019) | OraSure Technologies, Inc. | 2015-01-28 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S018) | Roche Molecular Systems, Inc. | 2015-01-15 |
| COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S052) | Roche Molecular Systems, Inc. | 2015-01-15 |