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.
Grifols Diagnostic Solutions Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 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 | 1788696414 | BK251300 | |||
| 218738 | 1750839048 | BK220746 | |||
| 218738 | 1542483517 | BK220736 | |||
| 193625 | 1531240276 | BK170162 | |||
| 218738 | 1531240276 | BK170162 | |||
| 193625 | 1555235461 | BK160125 | |||
| 218738 | 1555235461 | BK160125 | |||
| 193625 | 1217961905 | BK160084 | |||
| 193625 | 1773214927 | BK140150 | |||
| 218738 | 1773214927 | BK140150 | |||
| 193625 | 1958494323 | BK140101 | |||
| 193625 | 1991468017 | BK140092 | |||
| 193625 | 1207932573 | BK130067 | |||
| 218738 | 1438248855 | BK130052 | |||
| 193625 | 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#
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.
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.
GUDID#
Procleix Panther System - The Procleix Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Procleix assays from sample processing through amplification, detection, and data reduction. The Procleix assays are qualitative and/or quantitative in vitro nucleic acid amplification tests for the detection of pathogenic viruses in human specimens, as defined in the assay package insert.
2026-07-13
Procleix Panther System - The Procleix Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Procleix assays from sample processing through amplification, detection, and data reduction. The Procleix assays are qualitative and/or quantitative in vitro nucleic acid amplification tests for the detection of pathogenic viruses in human specimens, as defined in the assay package insert.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of Plasmodium species in whole blood specimens from human donors.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of Plasmodium species in whole blood specimens from human donors.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of Plasmodium species in whole blood specimens from human donors.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay Calibrators are used to determine the assay cutoff and assess assay run validity in the Procleix Plasmodium Assay.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of Plasmodium species in whole blood specimens from human donors.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of Plasmodium species in whole blood specimens from human donors.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of Plasmodium species in whole blood specimens from human donors.
2026-07-13
Procleix Plasmodium Assay - The Procleix Plasmodium Assay Calibrators are used to determine the assay cutoff and assess assay run validity in the Procleix Plasmodium Assay.
2026-07-13
Procleix Ultrio Plus Assay - 1K Kit Box 1
2018-02-06
Procleix Ultrio Plus Assay - 1K Kit Box 2
2018-02-06
Procleix Ultrio Plus Assay - 1K Kit Box 3
2018-02-06
Procleix Ultrio Plus Assay - 1K Kit Box 4
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 1
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 2
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 3
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 4
2018-02-06
Procleix Ultrio Plus Assay - 5K Kit Box 5
2018-02-06
Procleix Ultrio Plus Assay - HIV-1 dprobe kit
2018-02-06
Procleix Ultrio Plus Assay - HCV dprobe kit
2018-02-06
Procleix Ultrio Plus Assay - HBV dprobe kit
2018-02-06
Procleix Ultrio Plus Assay - Controls Kit
2018-02-06
Procleix Ultrio Plus Assay - Calibrators Kit
2018-02-06
Procleix Ultrio Plus Assay - Negative Calibrator Kit
2018-02-06
Procleix Ultrio Plus Assay - Negative Control Kit
2018-02-06
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