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:

FDA Registration(s)
Registration Number1000124057
FEI Number1000124057
NameGRIFOLS DIAGNOSTIC SOLUTIONS INC.
Owner & OperatorGrifols Diagnostic Solutions Inc.
Contact Address4560 Horton Street
Emeryville CA 94608 US
Official Correspondent
  • Diane Day
  • 01-510-9232579-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4560 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 Number2032600
FEI Number3003460312
NameGrifols Diagnostic Solutions Inc.
Owner & OperatorGrifols Diagnostic Solutions Inc.
Contact Address4560 Horton Street
Emeryville CA 94608 US
Official Correspondent
  • Diane Day
  • 01-510-9232579-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10808 WILLOW CT.
SAN DIEGO, CA 92127 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
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
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress® System 7417432022-02-24
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress® System 7416322021-07-09
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress® System 7408072019-05-17
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Parasite Transport Medium 2019-03-28
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Babesia Assay 2019-03-28
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Babesia Assay 2019-03-28
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Babesia Assay 2019-03-28
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Babesia Assay 2019-03-28
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress System Software Version 2.02019-03-21
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Panther Lower Bay Fluids 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Panther Lower Bay Fluids 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Elite Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Zika Virus Assay 2019-03-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Free Testosterone enzyme immunoassay kit2018-11-20
Grifols Diagnostic Solutions Inc.
Procleix Zika Virus Assay2018-11-09
Grifols Diagnostic Solutions Inc.
Aptima Zika Virus Assay2018-11-09
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix System Fluid Preservative 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Syscheck 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Tigris Lower Bay Fluids 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Tigris Lower Bay Fluids 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Tigris Lower Bay Fluids 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Tigris Lower Bay Fluids 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix WNV Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix WNV Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix WNV Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix WNV Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix WNV Assay 2018-09-03
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix WNV Assay 2018-09-03
Grifols Diagnostic Solutions Inc.
Aptima HCV RNA Qualitative Assay2018-08-30
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-08-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress System Software 7407692018-07-06
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress® System 7184632018-07-06
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress® System 300550672018-07-06
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress System v3.02018-05-21
Grifols Diagnostic Solutions Inc.
Procleix Ultrio Plus Assay2018-05-11
Grifols Diagnostic Solutions Inc.
Procleix Ultrio Elite Assay2018-05-11
Grifols Diagnostic Solutions Inc.
Procleix Ultrio Assay2018-05-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Reagent Preparation Incubator (RPI250) - (120V / 240V)2018-05-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Reagent Preparation Incubator (RPI) - (120V / 240V)2018-05-11
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
DG Reader2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
DG Gel Extended Control2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Erytra2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
WADiana Compact2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
DG Therm2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
DG Spin2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Grifols Diluent2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
DG Gel 8 Neutral2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
TRITURUS2018-04-20
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Ultrio Plus Assay 2018-03-29
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
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Procleix Xpress System2016-09-21
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
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020021434250Barcelona ,Spain -> Norfolk, VirginiaWASH SOLUTIONS HS CODE: 340290SCAC: DSVFBL: B CN012359620 PKG
2020012021655Barcelona ,Spain -> Oakland, CaliforniaMEDICAL EQUIPMENT10 PKG
2019102117528Barcelona ,Spain -> Oakland, CaliforniaMEDICAL EQUIPMENT10 PKG
2019033015304Barcelona ,Spain -> Long Beach, California13 PACKAGES SLAC EMPTY BOTTLES13 PKG
2018120451591Barcelona ,Spain -> Miami, Florida4 PACKAGES SLAC LABORATORY MATERIAL4 PKG

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.