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Sign in to claim this brandWhat Horiba Abx makes
Horiba Abx manufactures in vitro diagnostics (IVDs) for laboratory use, including haematological cell analysers like the ABX MINILYSE and ABX PENTRA series for full blood count testing, as well as clinical chemistry analysers such as the ABX MICROS ES60 CT for protein assays and blood gas/electrolyte measurements. The company also produces calibrators and controls for C-reactive protein (CRP), albumin, ferritin, cystatin C, immunoglobulins, and other analytes, including spectrophotometric total protein kits. Devices like the Yumizen C1200 series support immunochemistry and enzyme-linked assays for specific biomarkers.
The company’s products are regulated under FDA pathways, including 510(k) clearances and UDI compliance, with devices classified as Class I and Class II. These diagnostics are listed in the FDA’s regulatory databases and are intended for clinical laboratory settings in the United States. The manufacturer operates from its US headquarters.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
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Catalogue (184)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Abx Pentra Hba1c Wb Control | 1220001704 | FDA UDI | Class I | Unknown |
| Abx Pentra Df 120 | 1280100042, 1280100043, 1280100044, 1280100046 | FDA UDI | Class II | Active |
| Yumizen C Urine Level 1 Control | 1300023946 | FDA UDI | Class I | Active |
| Abx Pentra Bilirubin, Total Cp | 1220001639 | FDA UDI | Class II | Active |
| Yumizen C1200 Urinary Proteins | 1300047912 | FDA UDI | Class I | Active |
| Abx Pentra Total Protein 100 Cp | 1220001932 | FDA UDI | Class II | Active |
| Abx Pentra Hba1c Wb | 1220001702 | FDA UDI | Class II | Unknown |
| Abx Pentra Reference-E | 3014029451 | FDA UDI | Class I | Active |
| Abx Pentra 400 Ise | 1280030052, 1280030046 | FDA UDI | Class I | Active |
| ABX Pentra N MultiControl | 1300054414 | FDA UDI | Class I | Active |
| MINIPACK AD60 (x4) | 1210606051 | FDA UDI | Class I | Unknown |
| Abx Pentra 400 Ise | 1280030035 | FDA UDI | Class I | Active |
| Yumizen C1200 Level 2 Protein Control | 1300023945 | FDA UDI | Class I | Active |
| Yumizen C1200 RF Cal | 1300023908 | FDA UDI | Class II | Active |
| Yumizen C1200 HDL Direct | 1300023852 | FDA UDI | Class I | Active |
| ABX Minotrol 16 | 5300100306 | FDA UDI | Class II | Active |
| Yumizen C1200 Amylase | 1300023831 | FDA UDI | Class II | Active |
| Yumizen C1200 Multi Cal | 1300023890 | FDA UDI | Class II | Active |
| Yumizen C1200 N Multi Control | 1300023938 | FDA UDI | Class I | Active |
| Abx Pentra Hdl Direct Cp | 1220001636 | EUDAMEDFDA UDI | Class I | Active |
| Abx Sps Evolution | 1280160014, 1280160016 | FDA UDI | Class I | Active |
| Yumizen C1200 Glucose HK | 1300023849 | FDA UDI | Class II | Active |
| Abx Pentra Ldh Ifcc Cp | 1220001871 | FDA UDI | Class II | Active |
| Abx Pentra Hba1c Wb Hemolysis Reagent | 1220001730 | FDA UDI | Class I | Unknown |
| Abx Sps Evolution | 1280160018, 1280160020 | FDA UDI | Class I | Active |
| Yumizen C1200 Direct Bilirubin | 1300023834 | FDA UDI | Class II | Active |
| Yumizen C1200 Magnesium | 1300023859 | FDA UDI | Class I | Active |
| Yumizen C1200 Immunoglobulin G | 1300023883 | FDA UDI | Class II | Active |
| Yumizen C1200 ALT | 1300023797 | FDA UDI | Class I | Active |
| Pentra C400 Ise | 1300018788 | FDA UDI | Class I | Active |
| Abx Pentra Micro-Alb Cal | 1220001966 | FDA UDI | Class II | Active |
| Yumizen C1200 Glucose HK | 1300023848 | FDA UDI | Class II | Active |
| Yumizen C1200 Lactate | 1300023854 | FDA UDI | Class I | Active |
| Abx Micros 60 Cs | 1280070077, 1280070078 | FDA UDI | Class II | Active |
| Yumizen C1200 CRPhs Cal | 1300071246 | FDA UDI | Class II | Active |
| Abx Pentra Tpu Cal | 1220001898 | FDA UDI | Class II | Active |
| ABX Pentra P MultiControl | 1300054415 | FDA UDI | Class I | Active |
| Abx Pentra Ast Cp | 1220001629 | FDA UDI | Class II | Active |
| Yumizen C1200 CO2 | 1300023833 | FDA UDI | Class II | Active |
| Abx Pentra Co2 Cal | 1220001648 | FDA UDI | Class II | Active |
| Abx Pentra Df 120 | 1280100045, 1280100059 | FDA UDI | Class II | Active |
| Abx Pentra Dx 120 | 1280100120, 1280100121, 1280100122, 1280100124 | FDA UDI | Class II | Active |
| Yumizen C1200 C02 Control | 1300023950 | FDA UDI | Class I | Active |
| Yumizen C1200 Ferritin Cal | 1300023902 | FDA UDI | Class II | Active |
| Yumizen C1200 Creatinine PAP | 1300023844 | FDA UDI | Class II | Active |
| Yumizen C1200 CRP | 1300023877 | FDA UDI | Class II | Active |
| Abx Pentra Micro Alb Control L/H | 1220001967 | FDA UDI | Class I | Active |
| Yumizen C1200 Cystatin C Cal | 1300023900 | FDA UDI | Class II | Active |
| ABX Minotrol 16 | 5300100312 | FDA UDI | Class II | Active |
| Abx Pentra Enzymatic Creatinine Cp | 1220001907 | FDA UDI | Class II | Active |
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