FDA Registration
Active
🇺🇸 United States
Grifols Diagnostic Solutions Inc.
Reg #: 2032600
·
FEI: 3003460312
·
Expires 2026
Products
14
Proprietary Names
27
Establishment Types
5
Classifications
14
Registration Details
- Registration Name
- Grifols Diagnostic Solutions Inc.
- Registration Number
- 2032600
- FEI Number
- 3003460312
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10808 WILLOW CT.
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92127
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK160125
Owner / Operator
- Firm Name
- Grifols Diagnostic Solutions Inc.
- Operator Number
- 10051675
- Address
- 4560 Horton Street
- City
- Emeryville
- State
- CA
- Postal Code
- 94608
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2018-05-11 |
| System, Test, Automated Blood Grouping And Antibody | KSZ | Class 2 | Hematology | No | 2024-07-18 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2023-02-24 |
| Reagents, Zika Virus Nucleic Acid | POA | Class N | Unknown | No | 2018-11-09 |
| Data Acquisition Software | PQQ | Class 2 | Clinical Chemistry | No | 2018-05-21 |
| Blood Establishment Computer Software And Accessories | MMH | Class 2 | Hematology | No | 2018-05-21 |
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. | QTM | Class 2 | Microbiology | No | 2022-12-21 |
| Quality Control For Molecular Immunohematology Tests | PFK | Class 2 | Hematology | No | 2025-06-20 |
| Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations | QHO | Class U | Microbiology | No | 2023-06-02 |
| Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | MZP | Class 2 | Microbiology | No | 2018-08-30 |
| Anti-Human Globulin | QHS | Class U | Hematology | No | 2024-07-09 |
| Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma | QBZ | Class 1 | Clinical Chemistry | No | 2019-03-21 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2018-05-11 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2021-11-18 |
Proprietary Names
Aptima HIV-1 Qualitative Assay
DG Gel ABO/Rh (2D)
DG Gel ABO/Rh (2D) (RT)
Procleix SysCheck
Aptima Zika Virus Assay
Procleix® WNV/Babesia Quality Control
ID CORE CONTROL
Procleix UltrioPlex E Assay
Procleix Dengue Virus Assay
Procleix Parvo/HAV Assay
Procleix HEV Assay
Procleix Plasmodium Assay
Procleix ArboPlex Assay
Aptima HCV RNA Qualitative Assay
Procleix Xpress System
DG Gel Coombs
Procleix Xpress System v3
Procleix Xpress System Software Version 2
Procleix Xpress System Software Version 2.1
Procleix Xpress System Software Version 4
Procleix Xpress System Software Version 2.2
Procleix Xpress System Software Version 3.2
Procleix® HIV-1/HCV/HBV Quality Control
Procleix Reagent Preparation Incubator (RPI) - (120V / 240V)
Procleix Reagent Preparation Incubator (RPI250) - (120V / 240V)
DG GEL 8 NEUTRAL
Procleix Reagent Equilibration System (RES)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility