Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032600

FEI Number

3003460312

Entity Name

Grifols Diagnostic Solutions Inc.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

10808 WILLOW CT., SAN DIEGO, CA 92127, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Grifols Diagnostic Solutions Inc. (Owner Number: 10051675)

Owner / Operator Contact Address

4560 Horton Street, Emeryville, CA 94608, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK220736

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2018-05-11
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2024-07-18
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2023-02-24
POA	Reagents, Zika Virus Nucleic Acid	Unknown	Class N	N/A	2018-11-09
PQQ	Data Acquisition Software	Clinical Chemistry	Class 2	862.2570	2018-05-21
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2018-05-21
QTM	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.	Microbiology	Class 2	866.3920	2022-12-21
PFK	Quality Control For Molecular Immunohematology Tests	Hematology	Class 2	864.9650	2025-06-20
QHO	Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations	Microbiology	Class U	610.40	2023-06-02
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2018-08-30
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2016-09-21
QHS	Anti-Human Globulin	Hematology	Class U	660.50	2024-07-09
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2018-05-21
QBZ	Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma	Clinical Chemistry	Class 1	862.2750	2019-03-21
QTM	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.	Microbiology	Class 2	866.3920	2022-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Grifols Diagnostic Solutions Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1000124057	GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Emeryville, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032600. Last updated year: 2026. Please use registration number 2032600 when referencing this establishment in official correspondence.