Grifols Diagnostic Solutions Inc

FDA Filings

This page includes the latest FDA filings for Grifols Diagnostic Solutions Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Grifols Diagnostic Solutions Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• DIAGNOSTIC GRIFOLS, S.A.

FDA Registration(s)

• Registration Number: 1000124057
• FEI Number: 1000124057
• Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.
• Owner & Operator: Grifols Diagnostic Solutions Inc.
• Contact Address: 4560 Horton Street ; Emeryville CA 94608 US
• Official Correspondent:
  • Diane Day
  • 01-510-9232579-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4560 HORTON ST ; Emeryville, CA 94608 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 2032600
• FEI Number: 3003460312
• Name: Grifols Diagnostic Solutions Inc.
• Owner & Operator: Grifols Diagnostic Solutions Inc.
• Contact Address: 4560 Horton Street ; Emeryville CA 94608 US
• Official Correspondent:
  • Diane Day
  • 01-510-9232579-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10808 WILLOW CT. ; SAN DIEGO, CA 92127 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00859882007948 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress System 742248	2023-06-19
GUDID 00850032683067 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Babesia/WNV Quality Control	2023-02-23
GUDID 00850032683050 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Babesia/WNV Quality Control	2023-02-23
GUDID 00850032683043 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Babesia/WNV Quality Control	2023-02-23
GUDID 00850032683036 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix HIV-1/HCV/HBV Quality Control	2023-02-23
GUDID 00850032683029 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix HIV-1/HCV/HBV Quality Control	2023-02-23
GUDID 00850032683012 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix HIV-1/HCV/HBV Quality Control	2023-02-23
GUDID 00850032683005 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix HIV-1/HCV/HBV Quality Control	2023-02-23
PMN BK220746 Grifols Diagnostic Solutions Inc.	A Device Indicated For Use In A Test System To Estimate Test Precision Or To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation.	2022-10-14
PMN BK220736 Grifols Diagnostic Solutions Inc.	A Device Indicated For Use In A Test System To Estimate Test Precision Or To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation.	2022-09-16
GUDID 00866489000098 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress® System 741743	2022-02-24
GUDID 00859882007764 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress® System 741632	2021-07-09
GUDID 00866489000029 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress® System 740807	2019-05-17
GUDID 00859882007757 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Parasite Transport Medium	2019-03-28
GUDID 00859882007740 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Babesia Assay	2019-03-28
GUDID 00859882007733 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Babesia Assay	2019-03-28
GUDID 00859882007726 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Babesia Assay	2019-03-28
GUDID 00859882007719 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Babesia Assay	2019-03-28
QBZ GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress System Software Version 2.0	2019-03-21
GUDID 00859882007696 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007689 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007672 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007665 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007658 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
GUDID 00859882007641 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
GUDID 00859882007634 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
GUDID 00859882007627 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Panther Lower Bay Fluids	2019-03-11
GUDID 00859882007610 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Panther Lower Bay Fluids	2019-03-11
GUDID 00859882007603 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007597 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007580 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007573 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007566 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007559 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007542 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007535 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007528 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Elite Assay	2019-03-11
GUDID 00859882007504 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
GUDID 00859882007481 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
GUDID 00859882007474 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
GUDID 00859882007467 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
GUDID 00859882007450 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Zika Virus Assay	2019-03-11
PMN K030730 | CDZ GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Free Testosterone enzyme immunoassay kit	2018-11-20
POA Grifols Diagnostic Solutions Inc.	Procleix Zika Virus Assay	2018-11-09
POA Grifols Diagnostic Solutions Inc.	Aptima Zika Virus Assay	2018-11-09
GUDID 00859882007412 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix System Fluid Preservative	2018-09-03
GUDID 00859882007405 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Syscheck	2018-09-03
GUDID 00859882007399 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Tigris Lower Bay Fluids	2018-09-03
GUDID 00859882007382 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Tigris Lower Bay Fluids	2018-09-03
GUDID 00859882007375 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Tigris Lower Bay Fluids	2018-09-03
GUDID 00859882007368 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Tigris Lower Bay Fluids	2018-09-03
GUDID 00859882007351 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007344 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007337 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007320 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007313 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007306 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007290 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007283 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007276 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007269 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007252 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007245 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007238 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007221 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Assay	2018-09-03
GUDID 00859882007054 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix WNV Assay	2018-09-03
GUDID 00859882007047 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix WNV Assay	2018-09-03
GUDID 00859882007030 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix WNV Assay	2018-09-03
GUDID 00859882007023 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix WNV Assay	2018-09-03
GUDID 00859882007016 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix WNV Assay	2018-09-03
GUDID 00859882007009 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix WNV Assay	2018-09-03
PMN P020011 | MZP Grifols Diagnostic Solutions Inc.	Aptima HCV RNA Qualitative Assay	2018-08-30
GUDID 00859882007078 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-08-29
GUDID 00866489000036 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress System Software 740769	2018-07-06
GUDID 00866489000012 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress® System 718463	2018-07-06
GUDID 00866489000005 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress® System 30055067	2018-07-06
PMN BK170162 | MMH GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress System v3.0	2018-05-21
MZF Grifols Diagnostic Solutions Inc.	Procleix Ultrio Plus Assay	2018-05-11
MZF Grifols Diagnostic Solutions Inc.	Procleix Ultrio Elite Assay	2018-05-11
MZF Grifols Diagnostic Solutions Inc.	Procleix Ultrio Assay	2018-05-11
LXG GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Reagent Preparation Incubator (RPI250) - (120V / 240V)	2018-05-11
LXG GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Reagent Preparation Incubator (RPI) - (120V / 240V)	2018-05-11
PMN BK140101 | PBC GRIFOLS DIAGNOSTIC SOLUTIONS INC.	DG Reader	2018-04-20
PMN BK140092 | KSF GRIFOLS DIAGNOSTIC SOLUTIONS INC.	DG Gel Extended Control	2018-04-20
PMN BK130067 | KSZ GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Erytra	2018-04-20
PMN BK130025 | KSZ GRIFOLS DIAGNOSTIC SOLUTIONS INC.	WADiana Compact	2018-04-20
PMN BK120046 | PBC GRIFOLS DIAGNOSTIC SOLUTIONS INC.	DG Therm	2018-04-20
PMN BK120045 | PBC GRIFOLS DIAGNOSTIC SOLUTIONS INC.	DG Spin	2018-04-20
PMN BK120044 | PBC GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Grifols Diluent	2018-04-20
PMN BK120043 | PBC GRIFOLS DIAGNOSTIC SOLUTIONS INC.	DG Gel 8 Neutral	2018-04-20
JJE GRIFOLS DIAGNOSTIC SOLUTIONS INC.	TRITURUS	2018-04-20
GUDID 00859882007214 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007207 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007191 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007184 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007177 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007160 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007153 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007146 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007139 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007122 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007115 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007108 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007092 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007085 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
GUDID 00859882007061 GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Ultrio Plus Assay	2018-03-29
PMN BK170162 Grifols Diagnostic Solutions Inc.	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2018-01-18
PMN BK140150 | MMH GRIFOLS DIAGNOSTIC SOLUTIONS INC.	Procleix Xpress System	2016-09-21
PMN BK140150 Grifols Diagnostic Solutions Inc.	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2014-08-27

Related Finance Registrations

NCAGE Code	7AJ96	GRIFOLS DIAGNOSTIC SOLUTIONS INC.
CAGE Code	7AJ96	GRIFOLS DIAGNOSTIC SOLUTIONS INC.
S.A.M. Registration	7AJ96 [56570085]	GRIFOLS DIAGNOSTIC SOLUTIONS INC.
SEC	0001637912	Grifols Diagnostic Solutions Inc. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020021434250	Barcelona ,Spain -> Norfolk, Virginia	WASH SOLUTIONS HS CODE: 340290SCAC: DSVFBL: B CN0123596	20 PKG
2020012021655	Barcelona ,Spain -> Oakland, California	MEDICAL EQUIPMENT	10 PKG
2019102117528	Barcelona ,Spain -> Oakland, California	MEDICAL EQUIPMENT	10 PKG
2019033015304	Barcelona ,Spain -> Long Beach, California	13 PACKAGES SLAC EMPTY BOTTLES	13 PKG
2018120451591	Barcelona ,Spain -> Miami, Florida	4 PACKAGES SLAC LABORATORY MATERIAL	4 PKG