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Grifols Diagnostic Solutions Inc.

United States·US-MF-000004304

Last updated September 17, 2026

About

Grifols Diagnostic includes innovative products to support transfusion medicine, clinical diagnostics, and clinical testing services. Get to know us!

From the manufacturer's own website. Source

Information

Country: United States
Address: 10808, Willow Court, San Diego, United States
Website: www.diagnostic.grifols.com
LinkedIn: linkedin.com/showcase/grifols-diagnostic
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Sumit Khurana
EUDAMED SRN: US-MF-000004304
FDA FEI Number: 3003460312
DUNS Number: —

Catalogue (117)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Procleix Tigris Lower Bay Fluids	Procleix Auto Detect Reagent Kit	FDA UDI	N/A	Active
Procleix HIV-1/HCV/HBV Quality Control	HIV-1 Positive Control	FDA UDI	Class II	Active
Procleix Xpress System Software	Version 3.0	FDA UDI	Class II	Active
Procleix Ultrio Assay	Negative Calibrators Kit	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	High Volume Calibrator Kit	FDA UDI	N/A	Active
Procleix Ultrio Assay	5K Kit Box 2	FDA UDI	N/A	Active
Procleix WNV/Babesia Quality Control	WNV Positive Control	FDA UDI	Class II	Active
Procleix Ultrio Assay	1K Kit Box 2	FDA UDI	N/A	Active
Procleix WNV Assay	Calibrators Kit (15 Sets)	FDA UDI	N/A	Active
Procleix Zika Virus Assay	1K Kit Box 1	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	Calibrators Kit	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	Discriminatory Probe Kit	FDA UDI	N/A	Active
Procleix WNV Assay	Kit Box 3	FDA UDI	N/A	Active
Procleix HIV-1/HCV/HBV Quality Control	HBV Positive Control	FDA UDI	Class II	Active
Procleix Ultrio Plus Assay	1K Kit Box 2	FDA UDI	N/A	Active
Procleix Ultrio Assay	HIV-1 Discriminatory Probe Reagent Kit	FDA UDI	N/A	Active
Procleix Babesia Assay	Box 2	FDA UDI	N/A	Active
Procleix WNV Assay	Kit Box 2	FDA UDI	N/A	Active
Procleix WNV/Babesia Quality Control	WNV/Babesia Negative Control	FDA UDI	Class II	Active
Procleix Ultrio Plus Assay	5K Kit Box 2	FDA UDI	N/A	Active
Procleix Zika Virus Assay	5K Kit Box 3	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	5K Kit Box 5	FDA UDI	N/A	Active
Procleix Tigris Lower Bay Fluids	Procleix Oil Kit	FDA UDI	N/A	Active
Procleix Xpress® System	Version 2.1	FDA UDI	Class I	Active
Procleix Ultrio Assay	Controls Kit	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	1K Kit Box 1	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	5K Kit Box 1	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	5K Kit Box 4	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	5K Kit Box 3	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	5K Kit Box 1	FDA UDI	N/A	Active
Procleix Ultrio Assay	Negative Controls Kit	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	1K Kit Box 1	FDA UDI	N/A	Active
Procleix Ultrio Assay	1K Kit Box 1	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	HIV-1 dprobe kit	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	Negative Calibrator Kit	FDA UDI	N/A	Active
Procleix Babesia Assay	Box 3	FDA UDI	N/A	Active
Procleix WNV Assay	1K Kit Box 2	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	Negative Control Kit	FDA UDI	N/A	Active
Procleix Ultrio Assay	5K Kit Box 3	FDA UDI	N/A	Active
Procleix Zika Virus Assay	5K Kit Box 1	FDA UDI	N/A	Active
Procleix Ultrio Assay	Calibrators Kit	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	1K Kit Box 4	FDA UDI	N/A	Active
Procleix Xpress® System	Version 3.2	FDA UDI	Class I	Active
Procleix Tigris Lower Bay Fluids	Procleix Buffer for Deactivation Fluid Kit	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	5K Kit Box 2	FDA UDI	N/A	Active
Procleix Ultrio Elite Assay	Positive Calibrator Kit	FDA UDI	N/A	Active
Procleix WNV/Babesia Quality Control	Babesia Positive Control	FDA UDI	Class II	Active
Procleix Ultrio Elite Assay	Negative Calibrator Kit	FDA UDI	N/A	Active
Procleix Ultrio Plus Assay	5K Kit Box 4	FDA UDI	N/A	Active
Procleix Zika Virus Assay	5K Calibrators	FDA UDI	N/A	Active

Related Companies

Authorised Representatives

Diagnostic Grifols, S.A. ES

Importers

Not available yet.

Notified Bodies

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Authorities

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