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Fujirebio Diagnostics, Inc.

Last updated September 17, 2026

About

Fujirebio is an R&D-driven company constantly developing new technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care.

From the manufacturer's own website. Source

Information

Country: US
Address: 201 Great Valley Parkway, Malvern, PA, 19355
Website: fdi.com
LinkedIn: linkedin.com/company/fujirebio-diagnostics-inc.
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2521625
DUNS Number: —

Catalogue (63)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Beckman Coulter PK TP System Control Set	PH3502	FDA UDI	Class II	Active
Serodia TP-PA	1626	FDA UDI	Class II	Active
Lumipulse G Wash Solution	4008248	FDA UDI	Class I	Active
Cyfra 21-1 Eia	211-10	FDA UDI	Class II	Active
AMH Control	660-20	FDA UDI	Class I	Active
Syphilis Control	2130170	FDA UDI	Class I	Active
Serodia TP-PA	1633	FDA UDI	Class II	Active
Roma	404-10US	FDA UDI	Class II	Active
Vitamin D Control	2130166	FDA UDI	Class I	Active
Mesomark	801-905	FDA UDI	Unclassified	Unknown
Emit Cyclosporine Sample	4008086	FDA UDI	Class II	Active
Lumipulse G ROMA	CL0004	FDA UDI	Class II	Active
Vitamin D Control	2130152	FDA UDI	Class I	Active
Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool	CL0012	FDA UDI	N/A	Active
Beckman Coulter PK CMV-PA SYSTEM Control Set	240226	FDA UDI	Class II	Active
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio	CL0073	FDA UDI	Class II	Active
Fdi Glucose Control Levels 1, 2 And 3	K092645	FDA 510(k)	Class I	Active
St Aia-Pack Bnp	K192380	FDA 510(k)	Class II	Active
Fdi Glucose Control Solution For Freestyle	K103450	FDA 510(k)	Class I	Active
Lumipulse G whole PTH	K190702	FDA 510(k)	Class II	Active
Roma (he4 Eia + Architect Ca 125 Ii)	K103358	FDA 510(k)	Class II	Active
ADVIA Centaur Cytokeratin Fragment 21-1	K250925	FDA 510(k)	Class II	Active
Lumipulse G Progesterone-N Calibrators	K163546	FDA 510(k)	Class II	Active
Lumipulse G ß-Amyloid Ratio (1-42/1-40)	DEN200072	FDA 510(k)	Class II	Active
Architect Bnp Assay, Model 8k28	K060964	FDA 510(k)	Class II	Active
Lumipulse G TP-N Immunoreaction Cartridge Set	K153145	FDA 510(k)	Class II	Active
Lumipulse G CA15-3	K192524	FDA 510(k)	Class II	Active
Architect Roma	K151502	FDA 510(k)	Class II	Active
He4 Eia, Model: 404-10 Us	K072939	FDA 510(k)	Class II	Active
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators	K142895	FDA 510(k)	Class II	Active
Fdtx Glucose Control Solution	K081915	FDA 510(k)	Class I	Active
Vitros Ca 19-9	K052889	FDA 510(k)	Class II	Active
Architect He4, Architect He4 Calibrators And Architect He4 Controls, Models 2, 2p54, 2p54-01, 2p54-10 Sp54-01,	K093957	FDA 510(k)	Class II	Active
Axsym Cortisol Assay	K033731	FDA 510(k)	Class II	Active
Lumipulse G Prolactin	K163544	FDA 510(k)	Class II	Active
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS	K140436	FDA 510(k)	Class II	Active
Fujirebio Diagnostics Vitamin D Control	K110641	FDA 510(k)	Class I	Active
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators	K153361	FDA 510(k)	Class II	Active
Lumipulse G CA19-9-N	K200997	FDA 510(k)	Class II	Active
Fdi Glucose Control Solution For Use With Accu-Chek Aviva	K123612	FDA 510(k)	Class I	Active
Lumpipulse G CA19-9-N	K191973	FDA 510(k)	Class II	Active
Lumipulse G LH Calibrators	K163521	FDA 510(k)	Class II	Active
Fdi Level I And Level Ii Glucose Controls For The Embrace No Code	K133197	FDA 510(k)	Class I	Active
Architect Ca 15-3 Assay	K042732	FDA 510(k)	Class II	Active
Fdi Glucose Control Solution For Aviva	K110436	FDA 510(k)	Class I	Active
Architect Ca 19-9xr Assay	K052000	FDA 510(k)	Class II	Active
Lumipulse G ROMA	K160090	FDA 510(k)	Class II	Active
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio	K242706	FDA 510(k)	Class II	Active
Architect Tacrolimus: Model 1l77	K070820	FDA 510(k)	Class II	Active
Architect Cyclosporine	K080751	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 11, 2025	Z-1305-2026	—	open, classified	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Dec 11, 2025	Z-1301-2026	—	open, classified	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Dec 11, 2025	Z-1304-2026	—	open, classified	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Dec 11, 2025	Z-1303-2026	—	open, classified	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Dec 11, 2025	Z-1302-2026	—	open, classified	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Dec 11, 2025	Z-1306-2026	—	open, classified	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Dec 11, 2025	Z-1307-2026	—	open, classified	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Jul 29, 2010	Z-1606-2011	—	terminated	presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.

FDA Establishments (1)

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

Fujirebio Diagnostics AB Molndal Vastra Gotaland · SE FEI 3027273565