| ARCHITECT HBSAG/HBSAG CONFIRMATORY (P060007/S023) | Abbott Laboratories | 2012-12-05 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S014) | DiaSorin, Inc. | 2012-11-30 |
| ETI-AB-EBK PLUS ASSAY (P990041/S016) | DiaSorin, Inc. | 2012-11-30 |
| ETI-MAK-2 PLUS ASSAY (P990038/S017) | DiaSorin, Inc. | 2012-11-30 |
| ETI-AB-AUK PLUS ASSAY (P990042/S013) | DiaSorin, Inc. | 2012-11-30 |
| ETI-EBK PLUS ASSAY (P990043/S017) | DiaSorin, Inc. | 2012-11-30 |
| ETI-AB-COREK PLUS ASSAY (P990045/S014) | DiaSorin, Inc. | 2012-11-30 |
| ARCHITECT CORE (P080023/S016) | Abbott Laboratories | 2012-11-27 |
| ARCHITECT CORE-M (P060035/S015) | Abbott Laboratories | 2012-11-27 |
| ARCHITECT HBSAG QUALITATIVE/CONFIMATORY (P110029/S007) | Abbott Laboratories | 2012-11-27 |
| ARCHITECT HBSAG/CONFIMATORY (P060007/S022) | Abbott Laboratories | 2012-11-27 |
| ARCHITECT AUSAB (P050051/S016) | Abbott Laboratories, Inc. | 2012-11-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK CALIBRATOR (P090028/S005) | Ortho-Clinical Diagnostics, Inc. | 2012-11-26 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S006) | Abbott Laboratories | 2012-11-19 |
| COBAS HPV TEST (P100020/S005) | Roche Molecular Systems, Inc. | 2012-11-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR (P100001/S004) | Ortho-Clinical Diagnostics | 2012-11-19 |
| QUANTIFERON -TB GOLD (P010033/S020) | Qiagen | 2012-11-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S030) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S004) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| VITROS ANTI-HBS (P000014/S026) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| VITROS ANTI-HBC IGM (P030026/S026) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S008) | Bio-Rad Laboratories | 2012-11-13 |
| VITROS ANTI-HCV (P010021/S023) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| VITROS ANTI-HBE (P100001/S003) | Ortho-Clinical Diagnostics | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S007) | Bio-Rad Laboratories | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| VITROS ANTI-HBC (P030024/S020) | Ortho-Clinical Diagnostics | 2012-11-13 |
| BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA) (P100025/S003) | Meridian Bioscience, Inc. | 2012-11-06 |
| COBAS HPV TEST (P100020/S007) | Roche Molecular Systems, Inc. | 2012-11-06 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM (P990012/S018) | Roche Diagnostics Corp. | 2012-11-02 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM (P990012/S017) | Roche Diagnostics Corp. | 2012-11-02 |
| ABBOTT REALTIME HCV (P100017/S003) | Abbott Molecular, Inc. | 2012-11-01 |
| ABBOTT REALTIME HBV (P080026/S004) | Abbott Molecular, Inc. | 2012-11-01 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S011) | Siemens Healthcare Diagnostics, Inc. | 2012-10-24 |
| COBAS HPV TEST (P100020/S002) | Roche Molecular Systems, Inc. | 2012-10-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S003) | Ortho-Clinical Diagnostics, Inc. | 2012-10-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S002) | Ortho-Clinical Diagnostics | 2012-10-17 |
| ADVIA CENTAUR HCV ASSAY (P030056/S007) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS (P030049/S010) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ADVIA CENTAUR HBC IGM ASSAY (P030040/S008) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ADVIA CENTAUR ANTI-HBS ASSAY (P030029/S013) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S005) | Abbott Laboratories | 2012-10-15 |
| ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY (P060007/S021) | Abbott Laboratories | 2012-10-15 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S009) | Siemens Healthcare Diagnostics | 2012-10-15 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007) | Gen-Probe Incorporated | 2012-10-12 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S040) | Roche Molecular Systems, Inc. | 2012-10-10 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM (P060030/S029) | Roche Molecular Systems, Inc. | 2012-10-10 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S027) | Roche Molecular Systems, Inc. | 2012-10-10 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 411 (P090007/S010) | Roche Diagnostics Corp. | 2012-10-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170 (P090009/S010) | Roche Diagnostics Corp. | 2012-10-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 (P090008/S011) | Roche Diagnostics Corp. | 2012-10-04 |
| ABBOTT REALTIME HCV (P100017/S002) | Abbott Molecular, Inc. | 2012-09-27 |
| ABBOTT REALTIME HBV ASSAY (P080026/S003) | Abbott Molecular, Inc. | 2012-09-26 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S023) | Roche Molecular Systems, Inc. | 2012-09-18 |
| COBAS AMPLICOR HCV TEST, V2.0/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S036) | Roche Molecular Systems, Inc. | 2012-09-18 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0 (P060030/S024) | Roche Molecular Systems, Inc. | 2012-09-18 |
| ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S004) | Abbott Laboratories | 2012-09-14 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S002) | Roche Molecular Systems, Inc. | 2012-09-14 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST, HIGH PURE/COBAS TAQMAN HBV TEST (P050028/S026) | Roche Molecular Systems, Inc. | 2012-09-14 |
| ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY (P060007/S020) | Abbott Laboratories | 2012-09-14 |
| COBAS HPV TEST (P100020/S006) | Roche Molecular Systems, Inc. | 2012-09-14 |
| COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST (P060030/S028) | Roche Molecular Systems, Inc. | 2012-09-14 |
| COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S039) | Roche Molecular Systems, Inc. | 2012-09-14 |
| T-SPOT .TB TEST (P070006/S008) | Oxford Immunotec, Ltd. | 2012-09-05 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S009) | Diasorin | 2012-09-05 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S010) | Diasorin | 2012-09-05 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S001) | Roche Molecular Systems, Inc. | 2012-09-05 |
| BREATH TEK UBTFOR H. PYLORI KIT (P100025/S001) | Meridian Bioscience, Inc. | 2012-09-05 |
| ARCHITECT AUSAB (P050051/S015) | Abbott Laboratories, Inc. | 2012-08-30 |
| ARCHITECT ANTI-HCV (P050042/S018) | Abbott Laboratories, Inc. | 2012-08-30 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S019) | Abbott Laboratories | 2012-08-30 |
| ARCHITECT CORE (P080023/S015) | Abbott Laboratories | 2012-08-30 |
| ARCHITECT CORE-M (P060035/S014) | Abbott Laboratories | 2012-08-30 |
| ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY (P110029/S003) | Abbott Laboratories | 2012-08-30 |
| ARCHITECT ANTI-HCV (P050042/S017) | Abbott Laboratories, Inc. | 2012-07-31 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S015) | Roche Molecular Systems, Inc. | 2012-07-12 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S016) | Roche Molecular Systems, Inc. | 2012-07-12 |
| CERVISTA HPV 16/18 (P080015/S008) | Hologic, Inc. | 2012-07-06 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037) | Roche Molecular Systems, Inc. | 2012-07-05 |
| ABBOTT ARCHITECT HBSAG QUALITATIVE / ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S002) | Abbott Laboratories | 2012-07-03 |
| CERVISTA HUMAN PAPILLOMA VIRUS (HPV) (P080014/S013) | Hologic, Inc. | 2012-07-03 |
| ABBOTT ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY (P060007/S018) | Abbott Laboratories | 2012-07-03 |
| COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0 (P050028/S025) | Roche Molecular Systems, Inc. | 2012-06-29 |
| COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S026) | Roche Molecular Systems, Inc. | 2012-06-29 |
| VERSANT HCV RNA QUALITATIVE ASSAY (P020011/S005) | Gen-Probe | 2012-06-25 |
| COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBAS AMPLICOR HCV TEST, V2.0 (P000012/S038) | Roche Molecular Systems, Inc. | 2012-06-07 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM (P060030/S025) | Roche Molecular Systems, Inc. | 2012-06-07 |
| COBAS HPV TEST (P100020/S003) | Roche Molecular Systems, Inc. | 2012-06-07 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S024) | Roche Molecular Systems, Inc. | 2012-06-07 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S019) | Ortho-Clinical Diagnostics | 2012-05-24 |
| CERVISTA HPV 16/18 (P080015/S007) | Hologic, Inc. | 2012-05-21 |
| CERVISTA HPV HR (P080014/S012) | Hologic, Inc. | 2012-05-21 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST (P890064/S027) | Qiagen Gaithersburg, Inc. | 2012-05-21 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090008/S006) | Roche Diagnostics Corp. | 2012-04-25 |
| ELECSYS ANTI-HBS (ANTI-HBS) TEST SYSTEM (P010054/S017) | Roche Diagnostics Corp. | 2012-04-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S001) | Ortho-Clinical Diagnostics | 2012-04-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S002) | Ortho-Clinical Diagnostics, Inc. | 2012-04-16 |
| ARCHTECT ANTI-HCV (P050042/S016) | Abbott Laboratories, Inc. | 2012-04-13 |
| ARCHITECT CORE (P080023/S013) | Abbott Laboratories | 2012-04-13 |