| Praxis Extended RAS Panel (P160038/S013) | Illumina, Inc. | 2019-08-08 |
| PD-L1 IHC 22C3 pharmDx (P150013/S016) | Agilent Technologies, Inc. | 2019-07-30 |
| FoundationOne CDx (F1CDx) (P170019/S008) | Foundation Medicine, Inc. | 2019-07-01 |
| FoundationOne CDx (P170019/S004) | Foundation Medicine, Inc. | 2019-07-01 |
| Praxis Extended RAS Panel (P160038/S011) | Illumina, Inc. | 2019-06-19 |
| Cologuard (P130017/S031) | Exact Sciences Corporation | 2019-06-13 |
| PD-L1 IHC 22C3 pharmDx (P150013/S014) | Agilent Technologies, Inc. | 2019-06-10 |
| cobas BRAF v600 Muttaion Test (P110020/S032) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas KRAS Mutation Test (P140023/S020) | Roche Molecular Systems, Inc. | 2019-05-22 |
| COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0 (P120019/S028) | Roche | 2019-05-22 |
| Oncomine Dx Target Test (P160045/S015) | Life Technologies Corporation | 2019-05-21 |
| Praxis Extended RAS Panel (P160038/S012) | Illumina, Inc. | 2019-05-16 |
| Cologuard Stool DNA-Based Colorectal Cancer Screening Test (P130017/S030) | Exact Sciences Corporation | 2019-05-16 |
| Cologuard (P130017/S027) | Exact Sciences Corporation | 2019-05-14 |
| PathVysion HER-2 DA Probe Kit (P980024/S020) | Abbott Molecular, Inc. | 2019-05-08 |
| UroVysion Bladder Cancer Kit (P030052/S025) | Abbott Molecular | 2019-05-08 |
| Vysis CLL FISH Probe Kit (P150041/S005) | Abbott Molecular, Inc. | 2019-05-08 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S018) | Abbott Molecular, Inc. | 2019-05-08 |
| PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody (P990081/S040) | Ventana Medical Systems, Inc. | 2019-05-06 |
| PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S039) | Ventana Medical Systems, Inc. | 2019-05-03 |
| INFORM HER2 Dual ISH DNA Probe Cocktail assays (P100027/S030) | Ventana Medical Systems, Inc. | 2019-05-03 |
| PD-L1 IHC 22C3 pharmDx (P150013/S012) | Agilent Technologies, Inc. | 2019-04-16 |
| BOND Oracle HER2 IHC System (P090015/S007) | Leica Biosystems | 2019-04-11 |
| FoundationOne CDx Assay (P170019/S005) | Foundation Medicine, Inc. | 2019-04-10 |
| Praxis Extended RAS Panel (P160038/S010) | Illumina, Inc. | 2019-03-25 |
| Cologuard (P130017/S028) | Exact Sciences Corporation | 2019-03-19 |
| Progensa PCA3 Assay (P100033/S010) | Gen-Probe Incorporated | 2019-03-15 |
| PD-L1 IHC 28-8 pharmDx (P150025/S011) | Agilent Technologies, Inc. | 2019-03-13 |
| EGFR pharmDx (P030044/S007) | Agilent Technologies, Inc. | 2019-03-13 |
| PD-L1 IHC 22C3 PharmDx (P150013/S015) | Agilent Technologies, Inc. | 2019-03-13 |
| COLOGUARD (P130017/S026) | Exact Sciences Corporation | 2019-03-11 |
| VENTANA PD-L1(SP142) Assay. (P160002/S009) | Ventana Medical Systems, Inc. | 2019-03-08 |
| BRACAnalysis CDx (P140020/S014) | Myriad Genetic Laboratories | 2019-03-06 |
| Praxis Extended RAS Panel (P160038/S009) | Illumina, Inc. | 2019-03-05 |
| Oncomine Dx Target Test (P160045/S014) | Life Technologies Corporation | 2019-03-05 |
| Praxis Extended RAS Panel (P160038/S008) | Illumina, Inc. | 2019-02-25 |
| Cologuard (P130017/S025) | Exact Sciences Corporation | 2019-02-20 |
| Oncomine Dx Target Test (P160045/S013) | Life Technologies Corporation | 2019-02-13 |
| BOND Oracle HER2 IHC System (P090015/S006) | Leica Biosystems | 2019-01-23 |
| EGFR pharmDx (P030044/S006) | Agilent Technologies, Inc. | 2019-01-17 |
| PD-L1 IHC 22C3 pharmDx (P150013/S013) | Agilent Technologies, Inc. | 2019-01-17 |
| PD-L1 IHC 28-8 pharmDx (P150025/S010) | Agilent Technologies, Inc. | 2019-01-17 |
| Praxis (MiSeqDx) Extended RAS Panel (P160038/S007) | Illumina, Inc. | 2019-01-08 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S004) | Invivoscribe Technologies, Inc. | 2018-12-21 |
| ThinPrep Processor and ThinPrep Imaging System (P950039/S037) | Hologic, Inc. | 2018-12-20 |
| BRACAnalysis CDx (P140020/S018) | Myriad Genetic Laboratories | 2018-12-19 |
| FoundationOne CDx (P170019/S002) | Foundation Medicine, Inc. | 2018-12-18 |
| cobas BRAF V600 Mutation Test (P110020/S031) | Roche Molecular Systems, Inc. | 2018-12-13 |
| cobas KRAS Mutation Test (P140023/S019) | Roche Molecular Systems, Inc. | 2018-12-13 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S026) | Roche | 2018-12-11 |
| Ventana ALK (D5f3) CDx Assay (P140025/S010) | Ventana Medical Systems, Inc. | 2018-12-07 |
| cobas BRAF V600 Mutation Test (P110020/S030) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas KRAS Mutation Test (P140023/S018) | Roche Molecular Systems, Inc. | 2018-12-07 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S003) | Invivoscribe Technologies, Inc. | 2018-12-07 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S025) | Roche | 2018-12-07 |
| Oncomine Dx Target Test (P160045/S012) | Life Technologies Corporation | 2018-11-29 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S002) | Invivoscribe Technologies, Inc. | 2018-11-28 |
| Oncomine Dx Target Test (P160045/S011) | Life Technologies Corporation | 2018-11-16 |
| Oncomine Dx Target Test (P160045/S010) | Life Technologies Corporation | 2018-10-30 |
| Cologuard (P130017/S024) | Exact Sciences Corporation | 2018-10-29 |
| BRACAnalysis CDx (P140020/S017) | Myriad Genetic Laboratories | 2018-10-25 |
| Progensa PCA3 Assay (P100033/S009) | Gen-Probe Incorporated | 2018-10-18 |
| BRACAnalysis CDx device (P140020/S015) | Myriad Genetic Laboratories | 2018-10-16 |
| BRACAnalysis CDx (P140020/S016) | Myriad Genetic Laboratories | 2018-10-16 |
| FoundationOne CDx (F1CDx) (P170019/S003) | Foundation Medicine, Inc. | 2018-10-11 |
| therascreen EGFR RGQ PCR Kit (P120022/S018) | QIAGEN GmbH | 2018-09-27 |
| Praxis Extended RAS Panel (P160038/S006) | Illumina, Inc. | 2018-09-20 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S024) | Roche | 2018-09-19 |
| cobas BRAF V600 Mutation Test (P110020/S029) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas KRAS Mutation Test (P140023/S017) | Roche Molecular Systems, Inc. | 2018-09-19 |
| VENTANA PD-L1 (SP263) Assay (P160046/S005) | Ventana Medical Systems, Inc. | 2018-09-13 |
| VENTANA PD-L1(SP142) Assay (P160002/S007) | Ventana Medical Systems, Inc. | 2018-09-13 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S029) | Ventana Medical Systems, Inc. | 2018-09-13 |
| PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S038) | Ventana Medical Systems, Inc. | 2018-09-13 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S009) | Ventana Medical Systems, Inc. | 2018-09-13 |
| Oncomine Dx Target (P160045/S005) | Life Technologies Corporation | 2018-09-06 |
| MiSeqDx Extended RAS Panel (P160038/S005) | Illumina, Inc. | 2018-09-04 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S017) | Abbott Molecular, Inc. | 2018-08-29 |
| UroVysion Bladder Cancer Kit (P030052/S024) | Abbott Molecular | 2018-08-29 |
| Vysis CLL FISH Probe Kit (P150041/S004) | Abbott Molecular, Inc. | 2018-08-29 |
| PathVysion HER-2 DNA Probe Kit (P980024/S019) | Abbott Molecular, Inc. | 2018-08-29 |
| Cologuard (P130017/S023) | Exact Sciences Corporation | 2018-08-24 |
| Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit (P120019/S019) | Roche | 2018-08-22 |
| cobas BRAF V600 Mutation Test (P110020/S028) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas KRAS Mutation Test (P140023/S016) | Roche Molecular Systems, Inc. | 2018-08-17 |
| PD-L1 IHC 22C3 pharmDx (P150013/S011) | Agilent Technologies, Inc. | 2018-08-16 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S023) | Roche | 2018-08-15 |
| Oncomine Dx Target Test (P160045/S008) | Life Technologies Corporation | 2018-08-14 |
| Cobas BRAF V600 Mutation Test (P110020/S027) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S016) | Abbott Molecular, Inc. | 2018-07-11 |
| Vysis CLL FISH Probe Kit (P150041/S003) | Abbott Molecular, Inc. | 2018-07-11 |
| Path Vysion HER-2 DNA Probe Kit (P980024/S018) | Abbott Molecular, Inc. | 2018-07-11 |
| UroVysion Bladder Cancer Kit (P030052/S023) | Abbott Molecular | 2018-07-11 |
| cobas EGFR Mutation Test, V2.0 (P120019/S022) | Roche | 2018-07-05 |
| cobas BRAF V600 Mutation Test (P110020/S026) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas KRAS Mutation Test (P140023/S015) | Roche Molecular Systems, Inc. | 2018-07-05 |
| Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit (P140023/S014) | Roche Molecular Systems, Inc. | 2018-07-03 |
| Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test (P110020/S025) | Roche Molecular Systems, Inc. | 2018-07-03 |
| Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit (P120019/S021) | Roche | 2018-07-03 |
| VENTANA PD-L1(SP142) CDX ASSAY (P160002/S006) | Ventana Medical Systems, Inc. | 2018-07-02 |