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Sign in to claim this brandFUJIFILM WAKO PURE CHEMICAL CORPORATION
Japan·JP-MF-000013944
Last updated May 27, 2026
What FUJIFILM WAKO PURE CHEMICAL CORPORATION makes
The company manufactures in vitro diagnostic (IVD) reagents, calibrators, controls, and kits for laboratory testing, including products for measuring high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, non-esterified fatty acids, total complement activity (CH50), and albumin. These items are designed for use in clinical chemistry analyzers, nephelometry, and turbidimetry systems, supporting diagnostic assessments of lipid profiles, metabolic markers, and immune function.
The portfolio includes devices classified as Class A, B, C, I, and II under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The company is based in Japan and adheres to international regulatory standards for IVD products, ensuring compliance with global market requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Japan
- Address
- 1-2, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan
- Website
- fujifilm.com
- —
- —
- [email protected]
- Phone
- 877-714-1924
- PRRC Contact
- Tsuyoshi Okamoto
- EUDAMED SRN
- JP-MF-000013944
- FDA FEI Number
- —
- DUNS Number
- 690598875
Catalogue (88)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| uTASWako i30 | 991-60301 | FDA UDI | Class II | Unknown |
| uTASWako DCP Control H | 991-61401 | FDA UDI | Class I | Unknown |
| uTASWako DCP Calibrator Set | 999-61201 | FDA UDI | Class II | Unknown |
| Autokit Micro Albumin Calibrator Set | 995-06101 | FDA UDI | Class I | Active |
| L-Type HDL-C Reagent 1 | 997-72591 | FDA UDI | Class I | Active |
| CH50 Calibrator | 997-43801 | FDA UDI | Class II | Active |
| L-Type LDL-C Reagent 1 | 999-00404 | FDA UDI | Class I | Active |
| HR Series NEFA-HR(2) Solvent A | 995-34791 | FDA UDI | Class I | Active |
| HR Series NEFA-HR(2) Solvent B | 993-35191 | FDA UDI | Class I | Active |
| uTASWako DCP Control L | 995-61301 | FDA UDI | Class I | Unknown |
| L-Type HDL-C Reagent 2 | 993-72691 | FDA UDI | Class I | Unknown |
| L-Type HDL-C Reagent 2 | 997-00201 | FDA UDI | Class II | Active |
| uTASWako AFP-L3 | 999-60601 | FDA UDI | Class II | Unknown |
| uTASWako AFP-L3 Sample Dilution Buffer | 997-61501 | FDA UDI | Class II | Unknown |
| Multi Calibrator Lipids | 464-01601 | FDA UDI | Class II | Unknown |
| NEFA Standard Solution | 276-76491 | FDA UDI | Class II | Unknown |
| Autokit Micro Albumin Control Set | 991-06201 | FDA UDI | Class I | Active |
| HR Series NEFA-HR(2) Color Reagent A | 999-34691 | FDA UDI | Class I | Active |
| L-Type HDL-C (Reagent 2) | 997-00201 | FDA UDI | Class II | Unknown |
| HDL-C/LDL-C Calibrator | 990-28011 | FDA UDI | Class II | Active |
| L-Type HDL-C (Reagent 1) | 991-00101 | FDA UDI | Class II | Unknown |
| Autokit CH50 | 995-40801 | FDA UDI | Class II | Active |
| uTASWako AFP-L3 Control L | 997-61001 | FDA UDI | Class I | Unknown |
| CH50 Calibrator | 997-43801 | FDA UDI | Class II | Unknown |
| uTASWako Wash Solution | 991-60801 | FDA UDI | Class II | Unknown |
| L-Type LDL-C Reagent 2 | 999-00504 | FDA UDI | Class I | Active |
| uTASWako i30 | 991-60301 | FDA UDI | Class II | Active |
| NEFA Linearity Material | 997-76491 | FDA UDI | Class I | Active |
| uTASWako DCP | 995-60701 | FDA UDI | Class II | Unknown |
| L-Type HDL-C Reagent 1 | 991-00101 | FDA UDI | Class II | Active |
| uTASWako AFP-L3 Calibrator Set | 997-60901 | FDA UDI | Class II | Unknown |
| L-Type HDL-C Reagent 2 | 993-72691 | FDA UDI | Class I | Active |
| Autokit CH50 | 995-40801 | FDA UDI | Class II | Unknown |
| uTASWako Chip Cassette | 993-61601 | FDA UDI | Class II | Unknown |
| HR Series NEFA-HR(2) Color Reagent B | 991-34891 | FDA UDI | Class I | Active |
| L-Type HDL-C Reagent 1 | 997-72591 | FDA UDI | Class I | Active |
| Multi Calibrator Lipids | 464-01601 | FDA UDI | Class II | Active |
| Complement Control | 991-43701 | FDA UDI | Class I | Active |
| NEFA Standard Solution | 276-76491 | FDA UDI | Class II | Active |
| uTASWako AFP-L3 Control H | 993-61101 | FDA UDI | Class I | Unknown |
| HDL-C/LDL-C Calibrator | 990-28011 | FDA UDI | Class II | Active |
| Autokit Micro Albumin | 999-06001 | FDA UDI | Class I | Active |
| Autokit Micro Albumin Calibrator Set | 995-06101 | FDA UDI | Class I | Unknown |
| L-Type Total Bilirubin Reagent 1 | 992-24291 | EUDAMED | Class B | Active |
| BC Tip 1000-R | 991-05101 | EUDAMED | Class A | Active |
| μTASWako AFP-L3 Control H | 993-61101 | EUDAMEDFDA UDI | Class C | Active |
| Bilirubin Calibrator | 994-24491 | EUDAMED | Class B | Active |
| μTASWako DCP Calibrator Set | 999-61201 | EUDAMEDFDA UDI | Class C | Active |
| μTASWako AFP-L3 Calibrator Set | 997-60901 | EUDAMEDFDA UDI | Class C | Active |
| μTASWako AFP-L3 | 999-60601 | EUDAMEDFDA UDI | Class C | Active |
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