Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGrifols 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
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Sumit Khurana
- EUDAMED SRN
- US-MF-000004304
- FDA FEI Number
- 3003460312
- DUNS Number
- —
Catalogue (117)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Procleix Ultrio Plus Assay | 5K Kit Box 3 | FDA UDI | N/A | Active |
| Procleix System Fluid Preservative | Procleix System Fluid Preservative Kit | FDA UDI | N/A | Active |
| Procleix WNV Assay | Kit Box 4 | FDA UDI | N/A | Active |
| Procleix Ultrio Assay | HBV Discriminatory Probe Reagent Kit | FDA UDI | N/A | Active |
| Procleix Ultrio Assay | 1K Kit Box 3 | FDA UDI | N/A | Active |
| Procleix Ultrio Elite Assay | Low Volume Calibrator Kit | FDA UDI | N/A | Active |
| Procleix WNV Assay | Kit Box 1 | FDA UDI | N/A | Active |
| Procleix Zika Virus Assay | 1K Kit Box 3 | FDA UDI | N/A | Active |
| Procleix HIV-1/HCV/HBV Quality Control | HIV-1/HCV/HBV Negative Control | FDA UDI | Class II | Active |
| Procleix Babesia Assay | Box 1 | FDA UDI | N/A | Active |
| Procleix Zika Virus Assay | 1K Calibrators | FDA UDI | N/A | Active |
| Procleix Ultrio Assay | 5K Kit Box 1 | FDA UDI | N/A | Active |
| Procleix Ultrio Plus Assay | HCV dprobe kit | FDA UDI | N/A | Active |
| Procleix Xpress System | Version 4.0 | FDA UDI | Class I | Active |
| Procleix Tigris Lower Bay Fluids | Procleix Wash Solution Kit | FDA UDI | N/A | Active |
| Procleix Xpress® System | Version 2.0 | FDA UDI | Class I | Active |
| Procleix Babesia Assay | Calibrators | FDA UDI | N/A | Active |
| Procleix WNV Assay | Calibrators Kit | FDA UDI | N/A | Active |
| Procleix Xpress® System | 718463 | FDA UDI | Class II | Active |
| Procleix Ultrio Assay | 5K Kit Box 4 | FDA UDI | N/A | Active |
| Procleix HIV-1/HCV/HBV Quality Control | HCV Positive Control | FDA UDI | Class II | Active |
| Procleix Ultrio Plus Assay | 1K Kit Box 4 | FDA UDI | N/A | Active |
| Procleix Ultrio Plus Assay | Controls Kit | FDA UDI | N/A | Active |
| Procleix WNV Assay | 1K Kit Box 3 | FDA UDI | N/A | Active |
| Procleix Ultrio Plus Assay | 1K Kit Box 3 | FDA UDI | N/A | Active |
| Procleix Zika Virus Assay | 5K Kit Box 2 | FDA UDI | N/A | Active |
| Procleix Ultrio Elite Assay | 1K Kit Box 2 | FDA UDI | N/A | Active |
| Procleix Ultrio Assay | HCV Discriminatory Probe Reagent Kit | FDA UDI | N/A | Active |
| Procleix WNV Assay | Controls Kit | FDA UDI | N/A | Active |
| Procleix Ultrio Elite Assay | 1K Kit Box 3 | FDA UDI | N/A | Active |
| Procleix Zika Virus Assay | 1K Kit Box 2 | FDA UDI | N/A | Active |
| Procleix WNV Assay | 1K Kit Box 1 | FDA UDI | N/A | Active |
| Procleix Ultrio Plus Assay | HBV dprobe kit | FDA UDI | N/A | Active |
| Procleix SysCheck | 301046E | EUDAMEDFDA UDI | Class A | Active |
| Procleix Assay Fluids Kit | 303344 | EUDAMEDFDA UDI | Class A | Active |
| Reagents For Determ. Cholesterol/Serum | K800682 | FDA 510(k) | Class I | Active |
| Reagent For Determ. Creatine Phosphokina | K800684 | FDA 510(k) | Class II | Active |
| Reagents For Determ. Albumin In Human | K800678 | FDA 510(k) | Class II | Active |
| Reagent For Determ. Inorganic/Phosphorus | K800690 | FDA 510(k) | Class I | Active |
| Relief Plus One Reagent Strip Modification | K934892 | FDA 510(k) | Class II | Active |
| Reagent For Determ. Glutamic-Pyruvic- | K800689 | FDA 510(k) | Class I | Active |
| Reagents For Determ. Calcium In Human | K800680 | FDA 510(k) | Class II | Active |
| Reagent For Determ. Creatinine In H/Seru | K800685 | FDA 510(k) | Class II | Active |
| Reagent For Determ. Lactate/Dehydrogenas | K800691 | FDA 510(k) | Class II | Active |
| Reagent For Determ. Glutamic-Oxaloacetic | K800688 | FDA 510(k) | Class II | Active |
| Reagents For Determ. Co2 In Human Serum | K800681 | FDA 510(k) | Class II | Active |
| Reagents For Determ. Serum Iron In Human | K800677 | FDA 510(k) | Class I | Active |
| Reagent For Determ. Direct Bilirubin | K800686 | FDA 510(k) | Class II | Active |
| Uni-Check Reagent Strip | K924398 | FDA 510(k) | Class II | Active |
| Smac Replacement Reagents/Determ-Uric-Ac | K800672 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.