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Sign in to claim this brandFujirebio Europe N.V.
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Last updated May 23, 2026
What Fujirebio Europe N.V. makes
Fujirebio Europe N.V. manufactures the VERSANT HCV Genotype 2.0 Assay (LiPA), a diagnostic test used for identifying hepatitis C virus genotypes from patient samples.
This device is classified as Class II under FDA regulations and is listed under a Premarket Approval (PMA) application. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Fujirebio Europe N.V. manufacture?
Fujirebio Europe N.V. specializes in diagnostic devices. Specifically, they produce the VERSANT HCV Genotype 2.0 Assay (LiPA), which is an in vitro diagnostic test designed to identify hepatitis C virus genotypes from patient samples. This device falls under the category of laboratory tests used for infectious disease detection.
Where is Fujirebio Europe N.V. based, and how does that relate to their regulatory oversight?
Fujirebio Europe N.V. is based in the United States. Since the company operates within the U.S., its devices are subject to regulatory oversight by the U.S. Food and Drug Administration (FDA). The location ensures compliance with FDA regulations, including classification and approval pathways like Premarket Approval (PMA) for Class II devices.
How are the devices manufactured by Fujirebio Europe N.V. classified under FDA regulations?
The VERSANT HCV Genotype 2.0 Assay (LiPA) is classified as a Class II device under FDA regulations. This classification is based on the device’s intended use and risk level, where Class II devices require special controls to ensure safety and effectiveness beyond general controls. The classification influences the regulatory pathway, such as Premarket Approval (PMA), which is required for this type of device.
Which regulatory registries or databases list the devices manufactured by Fujirebio Europe N.V.?
The VERSANT HCV Genotype 2.0 Assay (LiPA) is listed under a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA). This means the device’s details, including its approval status and regulatory history, are documented in the FDA’s PMA registry. This registry serves as an official record of the device’s compliance and authorization for use in the U.S.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| INNO-LiPA HCV 2.0 Genotyping | 81659 | FDA UDI | Class II | Unknown |
| Auto-LIA 48 | 80629 | FDA UDI | Class I | Unknown |
| Lumipulse G pTau 217 Plasma Calibrators | 81557 | FDA UDI | Class II | Active |
| INNO-LiPA HCV 2.0 Genotyping | 81662 | FDA UDI | Class II | Unknown |
| Auto-LiPA 48 | 80628 | FDA UDI | Class I | Unknown |
| LiRAS for LiPA HCV v1 | 15687 | FDA UDI | Class II | Unknown |
| Tendigo | 80412 | FDA UDI | Class I | Active |
| INNO-LiPA HCV 2.0 Amp | 81663 | FDA UDI | Class II | Unknown |
| INNO-LiPA HCV 2.0 Amp | 81660 | FDA UDI | Class II | Unknown |
| TENDIGO Disposable Trays | Cat No. 80421 | FDA UDI | Class I | Active |
| INNO-LiPA HCV 2.0 Control | 81661 | FDA UDI | Class II | Unknown |
| Lumipulse B-Amyloid Plasma Controls | 81559 | FDA UDI | Class II | Active |
| Lumipulse pTau 217 Plasma Controls | 81558 | FDA UDI | Class II | Active |
| Lumipulse G pTau 217 Plasma Immunoreaction Cartridges | 81550 | FDA UDI | Class II | Active |
| VERSANT HCV Genotype 2.0 Assay (LiPA) | P160016 | FDA PMA | Class II | Active |
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