| ORAQUICK HCV RAPID ANTIBODY TEST (P080027) | OraSure Technologies, Inc. | 2010-06-25 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S010) | Roche Molecular Systems, Inc. | 2010-06-15 |
| PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S009) | Diasorin | 2010-06-10 |
| ELECSYS ANTI-HBS CALCHECK (P010054/S012) | Roche Diagnostics Corp. | 2010-06-04 |
| AXSYM CORE 2.0 (P060012/S002) | Abbott Laboratories, Inc. | 2010-06-03 |
| ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT (P990038/S013) | DiaSorin, Inc. | 2010-05-21 |
| ETI-AB-AUK PLUS KIT (P990042/S009) | DiaSorin, Inc. | 2010-05-21 |
| ETI-COREK-IGMK PLUS KIT (P990044/S010) | DiaSorin, Inc. | 2010-05-21 |
| ETI-AB-COREK PLUS KIT (P990045/S010) | DiaSorin, Inc. | 2010-05-21 |
| ETI-AB-EBK PLUS KIT (P990041/S012) | DiaSorin, Inc. | 2010-05-21 |
| ETI-EBK PLUS KIT (P990043/S013) | DiaSorin, Inc. | 2010-05-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S018) | Ortho-Clinical Diagnostics, Inc. | 2010-05-20 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S024) | Qiagen Gaithersburg, Inc. | 2010-05-17 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S022) | Qiagen Gaithersburg, Inc. | 2010-05-17 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S023) | Qiagen Gaithersburg, Inc. | 2010-05-17 |
| ABBOTT AXSYM ANTI-HCV (P970027/S008) | Abbott Laboratories | 2010-05-13 |
| ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER (P090007) | Roche Diagnostics Corp. | 2010-04-29 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER (P090008) | Roche Diagnostics Corp. | 2010-04-29 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER (P090009) | Roche Diagnostics Corp. | 2010-04-29 |
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S018) | Gen-Probe, Inc. | 2010-04-23 |
| VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S003) | Gen-Probe | 2010-04-23 |
| ADVIA CENTAUR HBSAG ASSAY (P030049/S008) | Siemens Healthcare Diagnostics | 2010-04-20 |
| AMPLICOR HCV TEST, VERSION 2.0 (P000010/S015) | Roche Molecular Systems, Inc. | 2010-04-08 |
| COBAS TAQMAN HBV TEST (P050028/S006) | Roche Molecular Systems, Inc. | 2010-04-08 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S007) | Roche Molecular Systems, Inc. | 2010-04-08 |
| COBAS AMPLICOR HCV TEST AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S022) | Roche Molecular Systems, Inc. | 2010-04-08 |
| AMPLICOR HCV TEST (P000010/S016) | Roche Molecular Systems, Inc. | 2010-04-07 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST (P890064/S021) | Qiagen Gaithersburg, Inc. | 2010-03-31 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S009) | Roche Molecular Systems, Inc. | 2010-03-24 |
| COBAS AMPLICOR HCV TEST (P000012/S024) | Roche Molecular Systems, Inc. | 2010-03-24 |
| T-SPOT .TB TEST (P070006/S004) | Oxford Immunotec, Ltd. | 2010-03-19 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE (P970055/S008) | Diasorin | 2010-03-19 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE (P970054/S008) | Diasorin | 2010-03-19 |
| ADVIA CENTAUR HBC IGM ASSAY (P030040/S007) | Siemens Healthcare Diagnostics | 2010-03-16 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S002) | Bio-Rad Laboratories | 2010-03-12 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S023) | Roche Molecular Systems, Inc. | 2010-03-08 |
| T-SPOT TB TEST (P070006/S003) | Oxford Immunotec, Ltd. | 2010-03-04 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S008) | Roche Molecular Systems, Inc. | 2010-02-04 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S007) | Roche Molecular Systems, Inc. | 2010-02-04 |
| QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE (P010033/S014) | Qiagen | 2010-01-29 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S007) | Siemens Healthcare Diagnostics | 2010-01-29 |
| QUANTIFERON - TB GOLD IN-TUBE (P010033/S015) | Qiagen | 2010-01-25 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010051/S007) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM (P010053/S006) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS (P010052/S007) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY (P010050/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| ETI-AB-COREK PLUS ASSAY (P990045/S009) | DiaSorin, Inc. | 2010-01-12 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S009) | DiaSorin, Inc. | 2010-01-12 |
| ETI-MAK-2 PLUS ASSAY (P990038/S012) | DiaSorin, Inc. | 2010-01-12 |
| ETI-AB-EBK PLUS ASSAY (P990041/S011) | DiaSorin, Inc. | 2010-01-12 |
| ETI-EBK PLUS ASSAY (P990043/S012) | DiaSorin, Inc. | 2010-01-12 |
| VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S019) | Ortho-Clinical Diagnostics, Inc. | 2010-01-11 |
| ELECSYS ANTI-HBS TEST SYSTEM (P010054/S011) | Roche Diagnostics Corp. | 2010-01-07 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S009) | Siemens Healthcare Diagnostics, Inc. | 2009-12-23 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS (P010052/S004) | Siemens Healthcare Diagnostics Products, Ltd. | 2009-12-16 |
| ABBOTT ARCHITECT CORE ASSAY (P080023/S001) | Abbott Laboratories | 2009-12-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI (P000044/S020) | Ortho-Clinical Diagnostics, Inc. | 2009-10-23 |
| T-SPOT .TB TEST (P070006/S002) | Oxford Immunotec, Ltd. | 2009-10-22 |
| ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040/S002) | Siemens Healthcare Diagnostics | 2009-10-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT (P000044/S022) | Ortho-Clinical Diagnostics, Inc. | 2009-10-20 |
| ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS (P040004/S002) | Siemens Healthcare Diagnostics | 2009-10-20 |
| COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S005) | Roche Molecular Systems, Inc. | 2009-10-13 |
| ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS (P030049/S002) | Siemens Healthcare Diagnostics | 2009-09-25 |
| ADVIA CENTAUR AHBS ASSAY (P030029/S008) | Siemens Healthcare Diagnostics | 2009-09-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S010) | Ortho-Clinical Diagnostics | 2009-09-11 |
| ADVIA CENTAUR ANTI-HBC IGM (P030040/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV (P030056/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY (P030049/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HBCT (P040004/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS (P030029/S006) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV (P030056/S006) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBCT (P040004/S006) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS (P030029/S007) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 HBSAG & HBSAG CONFIRMATORY (P030049/S007) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBC IGM (P030040/S006) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR HCV ON CENTAUR CP (P030056/S002) | Siemens Healthcare Diagnostics | 2009-08-13 |
| DIGENE HYBRID CAPTURE2 (P890064/S020) | Qiagen Gaithersburg, Inc. | 2009-08-12 |
| ADVIA CENTAUR AHBS (P030029/S003) | Siemens Healthcare Diagnostics | 2009-07-31 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S004) | Roche Molecular Systems, Inc. | 2009-07-30 |
| AMPLICOR HCV TEST (P000010/S014) | Roche Molecular Systems, Inc. | 2009-07-30 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S005) | Roche Molecular Systems, Inc. | 2009-07-30 |
| COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP (P000012/S021) | Roche Molecular Systems, Inc. | 2009-07-30 |
| ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM (P050051/S004) | Abbott Laboratories, Inc. | 2009-07-23 |
| CERVISTA HPV HR (P080014/S001) | Hologic, Inc. | 2009-07-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S016) | Ortho-Clinical Diagnostics, Inc. | 2009-07-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S016) | Ortho-Clinical Diagnostics, Inc. | 2009-07-15 |
| ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM (P060007/S002) | Abbott Laboratories | 2009-07-13 |
| ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV) (P970027/S007) | Abbott Laboratories | 2009-07-08 |
| ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS (P060035/S001) | Abbott Laboratories | 2009-06-23 |
| ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL (P050042/S005) | Abbott Laboratories, Inc. | 2009-06-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S018) | Ortho-Clinical Diagnostics, Inc. | 2009-06-12 |
| ADVIA CENTAUR ANTI-HBS (AHBS) (P030029/S004) | Siemens Healthcare Diagnostics | 2009-06-10 |
| ABBOTT ARCHITECT HBSAG (P060007/S003) | Abbott Laboratories | 2009-06-05 |
| IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY (P010050/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2009-06-02 |
| ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY (P030049/S006) | Siemens Healthcare Diagnostics | 2009-05-27 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S003) | Roche Molecular Systems, Inc. | 2009-05-22 |
| VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S001) | Gen-Probe | 2009-05-22 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S008) | Siemens Healthcare Diagnostics, Inc. | 2009-05-01 |
| VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM (P020022/S007) | Siemens Healthcare Diagnostics, Inc. | 2009-04-14 |
| ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS (P080023) | Abbott Laboratories | 2009-04-10 |