| Product Name | Manufacturer | Sample Type | Regulatory Status | Order number | Scientific/Diagnostic Field | Test Type /Platform |
|---|---|---|---|---|---|---|
| Lumipulse G ß-Amyloid 1-42 | Fujirebio | CSF | CE-IVDR | 230336 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G ß-Amyloid 1-40 | Fujirebio | CSF | CE-IVDR | 231524 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G Total Tau | Fujirebio | CSF | CE-IVDR | 230312 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G pTau 181 | Fujirebio | CSF | CE-IVDR | 230350 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G NfL | Fujirebio | CSF | RUO | 81426 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G pTau 217 | Fujirebio | CSF | RUO | 81702 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G ß-Amyloid 1-42 | Fujirebio | Plasma | RUO | 81301 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G ß-Amyloid 1-40 | Fujirebio | Plasma | RUO | 81298 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G pTau 181 | Fujirebio | Plasma | RUO | 81288 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G pTau 217 | Fujirebio | Plasma | CE-IVDR | 81544 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G NfL | Fujirebio | Plasma/Serum | CE-IVDR | 81632 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G ApoE4 | Fujirebio | Plasma | RUO | 81453 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G Pan-ApoE | Fujirebio | Plasma | RUO | 81449 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G GFAP | Fujirebio | Plasma/Serum | RUO | 261255 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G sTREM2 | Fujirebio | CSF/Plasma/Serum | RUO | 81656 | Neurodegeneration | fully automated G600/G1200 |
| Lumipulse G KL-6 | Fujirebio | Plasma/Serum | RUO | 234594 | Interstitial Pneumonia | fully automated G600/G1200 |
| Lumipulse G 25-OH Vitamin D | Fujirebio | Plasma/Serum | CE-IVDR | 234013 | Bone | fully automated G600/G1200 |
| Lumipulse G PTH (3rd Gen) | Fujirebio | Plasma/Serum | CE-IVDR | 297094 | Bone | fully automated G600/G1200 |
| Lumipulse G AFP | Fujirebio | Plasma/Serum | RUO | 233276 | Cancer Marker | fully automated G600/G1200 |
| Lumipulse G PIVKA-II | Fujirebio | Serum | RUO | 233887 | Cancer, Liver Marker | fully automated G600/G1200 |
| Lumipulse G Mesothelin | Fujirebio | Plasma/Serum | RUO | 200003 | Cancer Marker | fully automated G600/G1200 |
| Lumipulse G HMW Adiponectin | Fujirebio | Plasma/Serum | RUO | 296752 | Inflammation | fully automated G600/G1200 |
| Lumipulse G Procalcitonin (Brahms) | Fujirebio | Plasma/Serum | CE-IVDR | 297902 | Inflammation | fully automated G600/G1200 |
| Lumipulse G IL-6 | Fujirebio | Plasma/Serum | RUO | 293423 | Inflammation | fully automated G600/G1200 |
| Lumipulse G AFP | Fujirebio | Plasma/Serum | RUO | 233276 | Liver Marker | fully automated G600/G1200 |
| Lumipulse G HBcrAg | Fujirebio | Plasma/Serum | RUO | 295601 | Liver Marker | fully automated G600/G1200 |
| Lumipulse G Renin | Fujirebio | Plasma/Serum | CE-IVDR | 298794 | Hypertension | fully automated G600/G1200 |
| Lumipulse G Aldosterone | Fujirebio | Plasma/Serum/Urine | CE-IVDR | 298558 | Hypertension | fully automated G600/G1200 |
| Lumipulse G Anti-Mullerian Hormone (AMH) | Fujirebio | Plasma/Serum | CE-IVDR | 298381 | Fertility | fully automated G600/G1200 |
| Lumipulse G ADxPLORER a-Synuclein | Fujirebio/Adx | Plasma/CSF | RUO | 70122 | Synukleinopathic Neurodegeneration | fully automated G1200 only |
| Lumipulse G ADxPLORER BD-Tau | Fujirebio/Adx | Plasma/Serum | RUO | 70104 | Amyloid associated Neurodegeneration | fully automated G1200 only |
| Lumipulse G ADxPLORER ß-Synuclein | Fujirebio/Adx | Serum/Plasma/CSF | RUO | 70107 | Neurodegeneration | fully automated G1200 only |
| Lumipulse G ADxPLORER Dopa Decarboxylase (DDC) | Fujirebio/Adx | CSF | RUO | 70110 | Neurodegeneration | fully automated G1200 only |
| Lumipulse G ADxPLORER Neurogranin | Fujirebio/Adx | CSF | RUO | 70113 | Synaptic Degeneration | fully automated G1200 only |
| Lumipulse G ADxPLORER Neuronal Pentraxin-2 (NPTX2) | Fujirebio/Adx | Serum/Plasma/CSF | RUO | 70101 | Synaptic Degeneration | fully automated G1200 only |
| Lumipulse G ADxPLORER pTau231 | Fujirebio/Adx | Plasma/CSF | RUO | 70116 | AD-specific Tau Pathology | fully automated G1200 only |
| Lumipulse G ADxPLORER VAMP-2 | Fujirebio/Adx | Serum/Plasma/CSF | RUO | 70119 | Synaptic Degeneration | fully automated G1200 only |
| AmpFire HPV Screening 16/18/HR | Atila | Different sample types | CE-IVDR | 80732 | Infectious Disease | Isothermal amplification with real time fluorescence detection |
| AmpFire HPV High Risk Genotyp | Atila | Different sample types | CE-IVDR | 80736 | Infectious Disease | Isothermal amplification with real time fluorescence detection |
| Selfscreen PreCursor-M AnoGYN | Selfscreen | Different sample types | RUO | 81524 | Infectious Disease | Multiplex real-time methylation-specific PCR assay |
| Selfscreen PreCursor-M+ | Selfscreen | Different sample types | CE-IVDR | 81352 | Infectious Disease | Multiplex real-time methylation-specific PCR assay |
| DiaPlexQ ApoE Genotyping kit | Solgent | Whole Blood | CE-IVD | 81311 | Neurodegeneration | RT-PCR |
| INNO-LIA ANA Update | Fujirebio | Serum | CE-IVDR | 80320 | Autoimmune Disease | Line Immunoblot |
| INNO-LIA HCV Score | Fujirebio | Plasma/Serum | CE-IVDR | 80538 | Infectious Disease | Line Immunoblot |
| INNO-LIA HIV I/II Score | Fujirebio | Plasma/Serum | CE-IVDR | 80540 | Infectious Disease | Line Immunoblot |
| INNO-LIA HTLV I/II Score | Fujirebio | Plasma/Serum | CE-IVDR | 80541 | Infectious Disease | Line Immunoblot |
| INNO-LIA Syphilis Score | Fujirebio | Plasma/Serum | CE-IVDR | 80542 | Infectious Disease | Line Immunoblot |
| INNO-LiPA HBV Genotyping | Fujirebio | Plasma/Serum | CE-IVDR | 80691 | Infectious Disease | Line Immunoblot |
| INNO-LiPA HPV Genotyping Extra II | Fujirebio | Plasma/Serum | CE-IVDR | 81534 | Infectious Disease | Line Immunoblot |
| INNOTEST HCV Ab IV | Fujirebio | Plasma/Serum | CE-IVDR | 80068 | Infectious Disease | Enzyme Immunoassay |
| INNOTEST HIV Antigen mAb | Fujirebio | Plasma/Serum | CE-IVDR | 81512 | Infectious Disease | Enzyme Immunoassay |
| INNOTEST hPLAP | Fujirebio | Serum/ Heparinized Plasma | RUO | 81711 | Tumor markers | Enzyme Immunoassay |
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