HyperRAB
Rabies Immune Globulin (Human)
GRIFOLS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1050373 | 1050373 | Grifols Therapeutics LLC | 1 | Y | 2026-01-01 | 8368 Clayton Blvd Clayton NC US 27520 |
| 1066369 | 3003346238 | Grifols USA, LLC. | 1 | Y | 2026-01-01 | 2410 Grifols Way Los Angeles CA US 90032 |
| 2032600 | 3003460312 | Grifols Diagnostic Solutions Inc. | 1 | N | 2026-01-01 | 10808 WILLOW CT. SAN DIEGO CA US 92127 |
| 1000124057 | 1000124057 | GRIFOLS DIAGNOSTIC SOLUTIONS INC. | 1 | Y | 2026-01-01 | 4560 HORTON ST Emeryville CA US 94608 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 193625 | 1241392944 | K882596 | MP TEST | LJZ | 1989-06-21 |
| 193625 | 1002039690 | K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | DHN | 2016-07-28 |
| 193625 | 1956428910 | K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | MST | 2013-12-05 |
| 193625 | 1718499627 | K120889 | AESKUSLIDES ANA HEP-2 | DHN | 2012-10-15 |
| 193625 | 1861435495 | K091860 | AESKULISA MPO, MODEL 30-7303US | MOB | 2010-02-23 |
| 193625 | 1450862261 | K081251 | MODIFICATION TO AESKULISA DS DNA G | LSW | 2008-05-13 |
| 193625 | 1476646175 | K081104 | AESKULISA ANA HEP-2, REF 30-7115US | LKJ | 2008-05-02 |
| 193625 | 1301474861 | K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | MST | 2006-02-07 |
| 193625 | 1478822296 | K051492 | AESKULISA ASCA A | NBT | 2005-11-14 |
| 193625 | 1633734339 | K041628 | AESKULISA DS DNA G | LSW | 2004-10-14 |
| 193625 | 1834122474 | K040953 | AESKULISA ANA HEP-2 | LJM | 2004-06-23 |
| 193625 | 1933235834 | K040463 | AESKULISA CARDIOLIPIN AGM | MID | 2004-05-12 |
| 193625 | 1503653609 | K032469 | AESKULISA ANA 8PRO | LLL | 2003-12-16 |
| 193625 | 1243395988 | K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | CDZ | 2003-08-18 |
| 218738 | 1750839048 | BK220746 | |||
| 218738 | 1542483517 | BK220736 | |||
| 218738 | 1531240276 | BK170162 | |||
| 193625 | 1531240276 | BK170162 | |||
| 218738 | 1555235461 | BK160125 | |||
| 193625 | 1555235461 | BK160125 | |||
| 193625 | 1217961905 | BK160084 | |||
| 218738 | 1773214927 | BK140150 | |||
| 193625 | 1773214927 | BK140150 | |||
| 193625 | 1958494323 | BK140101 | |||
| 193625 | 1991468017 | BK140092 | |||
| 193625 | 1207932573 | BK130067 | |||
| 193625 | 1438248855 | BK130052 | |||
| 218738 | 1438248855 | BK130052 | |||
| 193625 | 1246761923 | BK130025 | |||
| 193625 | 1576429745 | BK120046 | |||
| 193625 | 1693030367 | BK120045 | |||
| 193625 | 1870154613 | BK120044 | |||
| 193625 | 1703609470 | BK120043 | |||
| 193625 | 1169012172 | ||||
| 193625 | 1206892798 | ||||
| 193625 | 1736487793 | ||||
| 193625 | 1781995059 | ||||
| 193625 | 1902275443 | ||||
| 193625 | 2070627007 | ||||
| 218738 | 1169012172 | ||||
| 218738 | 1262841644 | ||||
| 218738 | 1286680607 | ||||
| 218738 | 1308626251 | ||||
| 218738 | 1348223207 | ||||
| 218738 | 1360028271 | ||||
| 218738 | 1550749791 | ||||
| 218738 | 1559118432 | ||||
| 218738 | 1564611574 | ||||
| 218738 | 1590009225 | ||||
| 218738 | 1746070474 | ||||
| 218738 | 1902275443 |
Product Codes Associated With Registrations#
NDC#
GamaSTAN
immune globulin (human)
FESILTY
fibrinogen, human-chmt
THROMBATE III
ANTITHROMBIN III (HUMAN)
THROMBATE III
ANTITHROMBIN III (HUMAN)
THROMBATE III
ANTITHROMBIN III (HUMAN)
Plasmanate
Plasma Protein Fraction (Human)
HYPERRAB
RABIES IMMUNE GLOBULIN (HUMAN)
HYPERRHO
RHO(D) IMMUNE GLOBULIN (HUMAN)
HyperTET
Tetanus Immune Globulin (Human)
GAMASTAN
IMMUNE GLOBULIN (HUMAN)
HYPERHEP B
HEPATITIS B IMMUNE GLOBULIN (HUMAN)
HYPERRHO
RHO(D) IMMUNE GLOBULIN (HUMAN)
Plasbumin
Albumin (Human)
Plasbumin
Albumin (Human)
Plasbumin
Albumin (Human)
PROLASTIN-C
ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
PROLASTIN-C
ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
Prolastin-C Liquid
Alpha1-Proteinase Inhibitor (Human)
PROLASTIN-C
ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
Gamunex-C
Immune Globulin (Human)
Gamunex-C
Immune Globulin (Human)
XEMBIFY
immune globulin subcutaneous, human-klhw
HUMAN ALBUMIN GRIFOLS
ALBUMIN (HUMAN)
Flebogamma
Immune Globulin (Human)
VISTASEAL
human fibrinogen, human thrombin
VISTASEAL
human fibrinogen, human thrombin
VISTASEAL
human fibrinogen, human thrombin
VISTASEAL
Human fibrinogen, human thrombin
Profilnine
factor ix complex
Profilnine
factor ix complex
Profilnine
factor ix complex
AlphaNine
COAGULATION FACTOR IX (HUMAN)
AlphaNine
COAGULATION FACTOR IX (HUMAN)
AlphaNine
COAGULATION FACTOR IX (HUMAN)
AlphaNine
COAGULATION FACTOR IX (HUMAN)
AlphaNine
COAGULATION FACTOR IX (HUMAN)
AlphaNine
COAGULATION FACTOR IX (HUMAN)
Alphanate
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Alphanate
Antihemophilic Factor/von Willebrand Factor Complex (Human)
PMN#
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.
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.
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
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
Grifols Diagnostic Solutions Inc.
GLIADIN IGA AND GLIADIN LGA
GRIFOLS USA, LLC
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
GRIFOLS USA, LLC
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
GRIFOLS
EU-TTG IGA AND EU-TTG IGG
GRIFOLS USA, INC.
GUDID#
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Assay - The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
2018-08-03
Procleix Ultrio Plus Assay - Negative Control Kit
2018-02-06
Procleix Ultrio Plus Assay - Negative Calibrator Kit
2018-02-06
Procleix Ultrio Plus Assay - Calibrators Kit
2018-02-06
Procleix Ultrio Plus Assay - Controls Kit
2018-02-06
Procleix Ultrio Plus Assay - HBV dprobe kit
2018-02-06
Procleix Ultrio Plus Assay - HCV dprobe kit
2018-02-06
Procleix Ultrio Plus Assay - HIV-1 dprobe kit
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 5
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 4
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 3
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 2
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 1
2018-02-06
Procleix Ultrio Plus Assay - 1K Kit Box 4
2018-02-06
Procleix Ultrio Plus Assay - 1K Kit Box 3
2018-02-06
Procleix Ultrio Plus Assay - 1K Kit Box 2
2018-02-06
Procleix Ultrio Plus Assay - 1K Kit Box 1
2018-02-06
Procleix WNV Assay - The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.
2025-08-13
Procleix WNV Assay - The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.
2025-08-13
Procleix WNV Assay - The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.
2025-08-13
Procleix WNV Assay - The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.
2025-08-13
Procleix Panther Lower Bay Fluids - A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen.
2019-02-27
Procleix Panther Lower Bay Fluids - A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen.
2019-02-27
Procleix WNV/Babesia Quality Control - Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
2023-02-15
Procleix WNV/Babesia Quality Control - Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
2023-02-15
Procleix WNV/Babesia Quality Control - Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
2023-02-15
Procleix Xpress System - The Procleix Xpress System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single Master Pool Tube (MPT), which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and MPT composition.The Procleix Xpress System is intended to create whole blood lysates and/or pools of whole blood lysates for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single MPT. The pooled or individual lysates may be used for further testing in Procleix systems.In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
2023-06-09