Product Code: GGP


Products Classified as GGP

2260Test, Qualitative And Quantitative Factor DeficiencyFactor Deficiency Test.

Total Product Life Cycle (TPLC) Devices

2260Test, Qualitative And Quantitative Factor DeficiencyFactor Deficiency Test.

FDA Consensus Standards

Test, Qualitative And Quantitative Factor Deficiency [21764]21 CFR §864.7290 🔎
Test, Qualitative And Quantitative Factor Deficiency [26729]21 CFR §864.7290 🔎

Pre-market Notifications for GGP

K223402HemosIL Von Willebrand Factor AntigenInstrumentation Laboratory Co.
K200033HemosIL Von Willebrand Factor AntigenInstrumentation Laboratory Co.
K193204Cryocheck Chromogenic Factor VIIIPrecision BioLogic
K183440CRYOcheck FVIII Inhibitor KitPrecision BioLogic Inc.
K181525INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbH
K133005HEMOSIL VON WILLEBRAND ACTIVITY ASSAYINSTRUMENTATION LABORATORY CO.
K102164HEMOSIL PROTEIN S ACTIVITY ASSAYINSTRUMENTATION LABORATORY CO.
K092170STA LIATEST FREE PSDIAGNOSTICA STAGO, INC.
K082631THROMBO TEK PSE, MODEL 90-480R2 DIAGNOSTICS, INC.
K082205FACTOR VIII ANTIBODY SCREENGENETIC TESTING INSTITUTE
K070635HEMOSIL PROCLOTINSTRUMENTATION LABORATORY CO.
K063323SPECTROLYSE PAI-1, MODEL 101201AMERICAN DIAGNOSTICA, INC.
K062430HEMOSIL PROTEIN CINSTRUMENTATION LABORATORY CO.
K053499HEMOSIL PROSINSTRUMENTATION LABORATORY CO.
K052825VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AGAFFINITY BIOLOGICALS INC.

Global Unique Device Identification Database

00811476010291Test, Qualitative And Quantitative Factor Deficiency
00811476010161Test, Qualitative And Quantitative Factor Deficiency
00811476010130Test, Qualitative And Quantitative Factor Deficiency
00811476010123Test, Qualitative And Quantitative Factor Deficiency
00811476010017Test, Qualitative And Quantitative Factor Deficiency
00811476010000Test, Qualitative And Quantitative Factor Deficiency
00859394006095Test, Qualitative And Quantitative Factor Deficiency
00855360006267Test, Qualitative And Quantitative Factor Deficiency
00855360006038Test, Qualitative And Quantitative Factor Deficiency
00855360006021Test, Qualitative And Quantitative Factor Deficiency
00855360006014Test, Qualitative And Quantitative Factor Deficiency
00855360006007Test, Qualitative And Quantitative Factor Deficiency
00850201006161TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY
00850201006154TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY
00850201006109TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Maude Adverse Events

FACTOR VIII CHROMOGENIC ASSAYSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-05-10
BERICHROM PROTEIN CSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-12-21
BERICHROM PROTEIN CSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-12-21
FACTOR VIII ANTIBODY SCREENIMMUCOR GTI DIAGNOSTICS, INC.2018-07-20
FACTOR VIII CHROMOGENIC ASSAYSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-11-22
FACTOR VIII CHROMOGENIC ASSAYSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-11-22
FACTOR VIII CHROMOGENIC ASSAYSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-11-22
FACTOR VIII CHROMOGENIC ASSAYSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2015-11-23
FACTOR VIII ANTIBODY SCREENIMMUCOR GTI DIAGNOSTICS, INC.2014-05-09
HEMOSIL VON WILLEBRAND FACTOR ACTIVITYINSTRUMENTATION LABORATORY CO.2012-05-24
HEMOSIL VON WILLEBRAND FACTOR ACTIVITYINSTRUMENTATION LABORATORY CO.2012-05-24
HEMOSIL VON WILLEBRAND FACTOR ACTIVITYINSTRUMENTATION LABORATORY CO.2012-03-20
HEMOSIL VON WILLEBRAND FACTOR ACTIVITYINSTRUMENTATION LABORATORY CO.2012-03-20
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