Is this your brand? Sign in to claim ownership.

FUJIREBIO INC.

Last updated May 24, 2026

What FUJIREBIO INC. makes

The company produces in vitro diagnostic (IVD) reagents and consumables for laboratory use, including buffered sample diluents, calibrators, and chemiluminescent immunoassay kits. These products are designed for measuring biomarkers such as amyloid beta components, tau protein, cancer antigen 125 (CA125), cancer antigen 15-3 (CA15-3), and prostate-specific markers. Specific offerings include specimen diluents, calibrator sets, and immunoreaction cartridges for automated immunoassay systems. Additional items include buffered wash solutions and reagents for use in diagnostic platforms like the Lumipulse G and Beckman Coulter PK systems.

The portfolio includes devices classified as Class I, Class II, and Unclassified under regulatory frameworks, with listings in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in clinical laboratories and diagnostic settings, adhering to applicable IVD regulations. The company operates within the United States, where these devices are subject to FDA oversight.

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 Inc. manufacture?

FujiRebio Inc. specializes in in vitro diagnostic (IVD) reagents and consumables for laboratory use. Their products include buffered sample diluents, calibrators (such as for amyloid beta components, CA125, and CA15-3), and chemiluminescent immunoassay kits. These are designed to measure biomarkers like amyloid beta, tau protein, cancer antigens, and prostate-specific markers, often used in automated immunoassay systems like the Lumipulse G and Beckman Coulter PK platforms.

Where is FujiRebio Inc. based, and how does that affect its devices?

FujiRebio Inc. is based in the United States, where its IVD devices are subject to FDA oversight. Since the company operates within the U.S., its products must comply with FDA regulations, including classification under the agency’s framework (Class I, Class II, or Unclassified). This ensures alignment with U.S. regulatory requirements for diagnostic testing and laboratory use.

Which regulatory registries list FujiRebio Inc.’s devices?

FujiRebio Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks authorized IVD products in the U.S., allowing healthcare providers and regulators to verify compliance and identify specific device details, such as classifications and intended uses.

How are FujiRebio Inc.’s devices classified under regulatory standards?

FujiRebio Inc.’s devices fall into three regulatory classifications: Class I (generally low-risk), Class II (moderate-risk with special controls), and Unclassified (where risk-based classification is pending or not applicable). Classification depends on factors like the device’s purpose, potential health impact, and the level of regulatory scrutiny required for safety and effectiveness in diagnostic testing.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: fdi.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 610-240-3800
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 710873907

Catalogue (58)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Lumipulse G Specimen Diluent 3	230879	FDA UDI	Class I	Active
Soda Lime for LUMIPULSE System	234440	FDA UDI	N/A	Active
Lumipulse G BRAHMS PCT Calibrator Set	234938	FDA UDI	Class II	Active
Lumipulse G E2-III Calibrators	233849	FDA UDI	Class II	Active
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator	235454	FDA UDI	Class II	Active
Lumipulse G Progesterone-N Calibrators	230893	FDA UDI	Class II	Unknown
Lumipulse G BRAHMS PCT Immunoreaction Cartridges	235058	FDA UDI	Class II	Active
Lumipulse G HE4 Immunoreaction Cartridges	234174	FDA UDI	Class II	Unknown
Lumipulse G 25-OH Vitamin D Calibrators	234020	FDA UDI	Class II	Unknown
Lumipulse PTH Controls	230213	FDA UDI	N/A	Unknown
Lumipulse G B-Amyloid 1-40 Calibrator Set	234891	FDA UDI	N/A	Active
Lumipulse G Testosterone Immunoreaction Cartridges	235393	FDA UDI	Class I	Active
Beckman Coulter PK TP System	226964	FDA UDI	Class II	Active
Lumipulse G LH Calibrators	230916	FDA UDI	Class II	Unknown
Lumipulse G Specimen Diluent 1	231203	FDA UDI	Class I	Active
Beckman Coulter PK CMV-PA System	227541	FDA UDI	Class II	Active
Lumipulse G CA125II Calibrators	230688	FDA UDI	Class II	Active
Lumipulse G Wash Solution	231173	FDA UDI	Class I	Active
Lumipulse G1200	234259	FDA UDI	Class I	Active
Lumipulse G whole PTH Immunoreaction Cartridges	230190	FDA UDI	N/A	Unknown
Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges	231432	FDA UDI	N/A	Active
Lumipulse G Specimen Diluent 2	230985	FDA UDI	Class I	Active
Lumipulse G CA 19-9-N Immunoreaction Cartridges	235126	FDA UDI	N/A	Unknown
Lumipulse B-Amyloid Controls	234907	FDA UDI	N/A	Active
Lumipulse G Substrate Solution	231197	FDA UDI	Class I	Active
Lumipulse G LH Immunoreaction Cartridges	235270	FDA UDI	Class I	Unknown
Lumipulse G HE4 Calibrators	234181	FDA UDI	Class II	Unknown
Lumipulse G B-Amyloid 1-42-N Plasma	235447	FDA UDI	Class II	Active
Lumipulse G TP-N Immunoreaction Cartridges Set	235041	FDA UDI	Class II	Active
Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges	260340	FDA UDI	N/A	Active
Lumipulse G TSH-III Immunoreaction Cartridges	235294	FDA UDI	Class II	Unknown
Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges	235089	FDA UDI	Class II	Unknown
Lumipulse G FSH-N Calibrators	230930	FDA UDI	Class II	Unknown
Lumipulse G FSH-N Immunoreaction Cartridges	235218	FDA UDI	Class I	Unknown
Lumipulse G CA125II Immunoreaction Cartridges	234273	FDA UDI	Class II	Active
Lumipulse G Specimen Diluent 6	234693	FDA UDI	Class I	Active
Lumipulse G Dilution Cartridges	230466	FDA UDI	N/A	Active
Lumipulse G CA 19-9-N Calibrators	230664	FDA UDI	N/A	Unknown
Lumipulse G Mesothelin Immunoreaction Cartridges	235157	FDA UDI	Unclassified	Active
Lumipulse G TSH-III Calibrators	231135	FDA UDI	Class II	Unknown
Lumipulse G Testosterone Calibrators	230862	FDA UDI	Class II	Active
Lumipulse G Prolactin Calibrators	230954	FDA UDI	Class II	Unknown
Lumipulse G B-Amyloid Controls (Plasma)-N	235485	FDA UDI	N/A	Unknown
Lumipulse G Whole PTH Calibrators	230206	FDA UDI	N/A	Unknown
Lumipulse G B-Amyloid 1-42 Calibrator Set	234884	FDA UDI	N/A	Active
Lumipulse G Progesterone-N Immunoreaction Cartridges	235256	FDA UDI	Class I	Unknown
Lumipulse G Mesothelin Calibrator	233436	FDA UDI	Unclassified	Active
Lumipulse G BHCG Immunoreaction Cartridges	235232	FDA UDI	Class II	Active
Lumipulse G CA 15-3 Immunoreaction Cartridges	235102	FDA UDI	N/A	Active
Lumipulse G CA 15-3 Calibrators	230640	FDA UDI	N/A	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Fujirebio Inc. Sagamihara-shi Kanagawa · JP FEI 3002895169