| ELECSYS HBEAG (P130015/S008) | Roche Diagnostics Operations, Inc. | 2016-11-22 |
| ELECSYS ANTI-HBS (P010054/S029) | Roche Diagnostics Corp. | 2016-11-22 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S024) | OraSure Technologies, Inc. | 2016-11-18 |
| ELECSYS ANTI-HCV II IMMUNOASSAY. (P140021/S007) | Roche Diagnostics Operations, Inc. | 2016-11-10 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, (P110029/S024) | Abbott Laboratories | 2016-11-10 |
| COBAS HBV TEST (P150014/S004) | Roche Molecular Systems, Inc. | 2016-10-31 |
| COBAS HCV TEST (P150015/S004) | Roche Molecular Systems, Inc. | 2016-10-31 |
| COBAS HBV TEST (P150014/S005) | Roche Molecular Systems, Inc. | 2016-10-31 |
| ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY (P110041/S003) | Siemens Corp. | 2016-10-26 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015/S007) | Roche Diagnostics Operations, Inc. | 2016-10-24 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S055) | Roche Molecular Systems, Inc. | 2016-10-18 |
| ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY (P090024/S001) | Siemens Healthcare Diagnostics | 2016-10-18 |
| COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit (P050028/S054) | Roche Molecular Systems, Inc. | 2016-10-18 |
| COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S029) | Roche Molecular Systems, Inc. | 2016-10-18 |
| COBAS HPV TEST (P100020/S021) | Roche Molecular Systems, Inc. | 2016-10-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR (P100001/S009) | Ortho-Clinical Diagnostics | 2016-10-10 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S006) | Gen-Probe Incorporated | 2016-09-19 |
| APTIMA HPV ASSAY (P100042/S008) | Gen-Probe Incorporated | 2016-09-19 |
| APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S009) | Gen-Probe | 2016-09-19 |
| APTIMA HPV ASSAY (P100042/S011) | Gen-Probe Incorporated | 2016-09-13 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S054) | Roche Molecular Systems, Inc. | 2016-09-13 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S009) | Gen-Probe Incorporated | 2016-09-13 |
| ADVIA Centaur® HCV assay (P030056/S009) | Siemens Healthcare Diagnostics | 2016-09-09 |
| QUANTIFERON-TB GOLD AND TB GOLD- Test (reference lab pack) (P010033/S030) | Qiagen | 2016-08-25 |
| ADVIA CENTAUR ANTI HBS2 ASSAY (P100039/S004) | Siemens Healthcare Diagnostics, Inc. | 2016-08-20 |
| QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack) (P010033/S029) | Qiagen | 2016-08-19 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S028) | Roche Molecular Systems, Inc. | 2016-08-18 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S053) | Roche Molecular Systems, Inc. | 2016-08-18 |
| COBAS AmpliPrep/Cobas TAQMAN HBV TEST and Cobas TaqMan HBV Test for user with The High Pure System (P050028/S053) | Roche Molecular Systems, Inc. | 2016-08-18 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S012) | Siemens Healthcare Diagnostics | 2016-08-11 |
| ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S011) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S024) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS ANTI-HCV II IMMUNOASSAY (P140021/S003) | Roche Diagnostics Operations, Inc. | 2016-08-08 |
| Elecsys Anti-HBc II, PreciControl Anti-HBc (P100031/S014) | Roche Diagnostics Corp. | 2016-08-08 |
| ELECSYS HBEAG IMMUNOASSAY (P130015/S005) | Roche Diagnostics Operations, Inc. | 2016-08-08 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S026) | Roche Diagnostics Corp. | 2016-08-08 |
| COBAS HPV TEST (P100020/S020) | Roche Molecular Systems, Inc. | 2016-08-05 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S027) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS HCV TEST (P150015/S003) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS HBV TEST (P150014/S003) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS AMPLICOR HCV (P000012/S056) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS TAQMAN HCV (P060030/S052) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS TAQMAN HBV TEST (P050028/S052) | Roche Molecular Systems, Inc. | 2016-08-04 |
| ELECSYS ANTI-HCV II TEST SYSTEM (P140021/S005) | Roche Diagnostics Operations, Inc. | 2016-07-25 |
| ABBOTT ARCHITECT AUSAB (P050051/S031) | Abbott Laboratories, Inc. | 2016-07-13 |
| COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS (P100020/S017) | Roche Molecular Systems, Inc. | 2016-07-07 |
| ABBOTT REALTIME HCV ASSAY (P100017/S018) | Abbott Molecular, Inc. | 2016-06-30 |
| ABBOTT REALTIME HCV GENOTYPE II ASSAY (P120012/S014) | Abbott Molecular | 2016-06-30 |
| ABBOTT REALTIME HCV ASSAY, ABBOTT REALTIME HCV CALIBRATOR KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT MSAMPLE PREPARATI (P100017/S017) | Abbott Molecular, Inc. | 2016-06-10 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P120012/S013) | Abbott Molecular | 2016-06-10 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S018) | DiaSorin, Inc. | 2016-06-08 |
| ETI-AB-EBK PLUS ASSAY (P990041/S020) | DiaSorin, Inc. | 2016-06-08 |
| ETI-AB-AUK PLUS ASSAY (P990042/S017) | DiaSorin, Inc. | 2016-06-08 |
| ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS (P990038/S021) | DiaSorin, Inc. | 2016-06-08 |
| ETI-AB-COREK PLUS ASSAY (P990045/S018) | DiaSorin, Inc. | 2016-06-08 |
| DIASORIN ETI-EBK PLUS ASSAY (P990043/S021) | DiaSorin, Inc. | 2016-06-08 |
| APTIMA HPV ASSAY (P100042/S010) | Gen-Probe Incorporated | 2016-05-20 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S023) | Roche Molecular Systems, Inc. | 2016-05-20 |
| COBAS HPV TEST (P100020/S019) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS TAQMAN HBV TEST (P050028/S051) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S051) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012/S055) | Roche Molecular Systems, Inc. | 2016-05-13 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S026) | Roche Molecular Systems, Inc. | 2016-05-13 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S023) | OraSure Technologies, Inc. | 2016-05-10 |
| COBAS TAQMAN HBV TEST (P050028/S050) | Roche Molecular Systems, Inc. | 2016-04-29 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S050) | Roche Molecular Systems, Inc. | 2016-04-29 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S025) | Roche Molecular Systems, Inc. | 2016-04-29 |
| COBAS HPV TEST (P100020/S018) | Roche Molecular Systems, Inc. | 2016-04-29 |
| COBAS HBV TEST (P150014/S002) | Roche Molecular Systems, Inc. | 2016-04-29 |
| COBAS HCV TEST (P150015/S002) | Roche Molecular Systems, Inc. | 2016-04-29 |
| QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE (P010033/S028) | Qiagen | 2016-04-27 |
| ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017/S015) | Abbott Molecular, Inc. | 2016-04-20 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012/S011) | Abbott Molecular | 2016-04-20 |
| digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk (P890064/S033) | Qiagen Gaithersburg, Inc. | 2016-04-15 |
| ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017/S016) | Abbott Molecular, Inc. | 2016-04-12 |
| ABBOTT REALTIME HBV ASSAY (P080026/S017) | Abbott Molecular, Inc. | 2016-04-12 |
| ELECSYS ANTI-HCV II IMMUNOASSAY (P140021/S002) | Roche Diagnostics Operations, Inc. | 2016-04-12 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012/S012) | Abbott Molecular | 2016-04-12 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029/S023) | Abbott Laboratories | 2016-04-06 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR (P000044/S034) | Ortho-Clinical Diagnostics, Inc. | 2016-03-30 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S008) | Gen-Probe Incorporated | 2016-03-28 |
| ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL (P050042/S033) | Abbott Laboratories, Inc. | 2016-03-24 |
| COBAS HCV TEST (P150015/S001) | Roche Molecular Systems, Inc. | 2016-03-24 |
| COBAS HBV TEST (P150014/S001) | Roche Molecular Systems, Inc. | 2016-03-24 |
| ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER (P090007/S015) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015/S006) | Roche Diagnostics Operations, Inc. | 2016-03-16 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG (P990012/S026) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBS (P010054/S028) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER (P090009/S015) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER (P090008/S017) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC (P100031/S016) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV (P140021/S006) | Roche Diagnostics Operations, Inc. | 2016-03-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032/S013) | Roche Diagnostics Corp. | 2016-03-16 |
| ADVIA CENTAUR AHBCM ASSAY (P030040/S009) | Siemens Healthcare Diagnostics | 2016-03-11 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S010) | Abbott Molecular | 2016-03-07 |
| PARVOVIRUS B19 IgG ENZYME IMMUNOASSAY (V519GUS) (P970054/S011) | Diasorin | 2016-03-03 |
| ELECSYS ANTI-HBC TEST SYSTEM (P100031/S015) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS HBSAG TEST SYSTEM (P990012/S025) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HBC TEST SYSTEM (P100032/S012) | Roche Diagnostics Corp. | 2016-02-24 |
| ELECSYS ANTI-HCV II TEST SYSTEM (P140021/S004) | Roche Diagnostics Operations, Inc. | 2016-02-24 |