GGN

Product Code: GGN


Products Classified as GGN

2258Plasma, Coagulation ControlMultipurpose System For In Vitro Coagulation Studies.

Total Product Life Cycle (TPLC) Devices

2258Plasma, Coagulation ControlMultipurpose System For In Vitro Coagulation Studies.

FDA Consensus Standards

Plasma, Coagulation Control [21764]21 CFR §864.5425 🔎
Plasma, Coagulation Control [26729]21 CFR §864.5425 🔎

Pre-market Notifications for GGN

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company LLC
K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMAINE STANDARDS COMPANY, LLC
K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMAINE STANDARDS COMPANY LLC
K161316George King Coumadin PlasmaGEORGE KING BIO-MEDICAL, INC.
K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMAINE STANDARDS COMPANY LLC
K150144VisuCon-F Low Fibrinogen Control PlasmaAFFINITY BIOLOGICALS INC.
K142132POOL NORMDiagnostics Stago S.A.S.
K133582HEMOSIL D-DIMER HS 500 CONTROLINSTRUMENTATION LABORATORY
K120977DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MICINTERNATIONAL TECHNIDYNE CORP.
K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2CLINIQA CORPORATION
K120014STA- COAG CONTROL (N+ABN) PLUSDIAGNOSTICA STAGO, INC.
K113211HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROLINSTRUMENTATION LABORATORY CO.
K110432VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABNAFFINITY BIOLOGICALS INC.
K103314CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROLMEDTRONIC INC.
K103313HEPARIN ASSAY CONTROLSMEDTRONIC INC.

Global Unique Device Identification Database

00365702129108PLASMA, COAGULATION CONTROL
00630414170794PLASMA, COAGULATION CONTROL
00630414025148PLASMA, COAGULATION CONTROL
10627944000087Plasma, Coagulation Control
10627944000070Plasma, Coagulation Control
10627944000063Plasma, Coagulation Control
00708872000011Plasma, Coagulation Control
00708872000004Plasma, Coagulation Control
00763000014919Plasma, coagulation control
00816426021273Plasma, Coagulation Control
00816426021266Plasma, Coagulation Control
00816426020870Plasma, Coagulation Control
00815696021105Plasma, Coagulation Control
00815696021099Plasma, Coagulation Control
00815696021044Plasma, Coagulation Control

Maude Adverse Events

DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMALACCRIVA DIAGNOSTICS2018-06-26
DIRECTCHECK ACT-LR QUALITY CONTROL, NORMALACCRIVA DIAGNOSTICS2018-05-11
CONTROL PLASMA NSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-04-17
ACT VIALED WHOLE BLOOD CONTROLACCRIVA DIAGNOSTICS2018-03-08
DIRECTCHECK ACT+ ABNORMALACCRIVA DIAGNOSTICS2017-11-02
DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMALACCRIVA DIAGNOSTICS2017-09-01
HEMOCHRON DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMALACCRIVA DIAGNOSTICS2017-07-24
DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMALACCRIVA DIAGNOSTICS2017-07-24
DIRECTCHECK CITRATE PT ABNORMALACCRIVA DIAGNOSTICS2017-05-03
DIRECTCHECK ACT-LR QUALITY CONTROL, NORMALACCRIVA DIAGNOSTICS2017-04-21
DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMALACCRIVA DIAGNOSTICS2017-04-12
HEMOCHRON DIRECTCHECK ACT-LR QUALITY CONTROL ABNORMALACCRIVA DIAGNOSTICS2017-03-16
DIRECTCHECK PT QUALITY CONTROL, ABNORMALACCRIVA DIAGNOSTICS2017-03-16
HEMOCHRON DIRECTCHECK NORMAL ACT-LRACCRIVA DIAGNOSTICS2017-01-12
HEMOCHRON DIRECTCHECK ACT-LR ABNORMALACCRIVA DIAGNOSTICS2017-01-11
HEMOCHRON JR. DIRECTCHECK CITRATE PT ABNORMALACCRIVA DIAGNOSTICS2016-12-02
DIRECTCHECK ACT-LR ABNORMAL QUALITY CONTROLACCRIVA DIAGNOSTICS2016-11-23
DIRECTCHECK NORMAL ACT+ACCRIVA DIAGNOSTICS2016-11-01
DIRECTCHECK ACT+ NORMALACCRIVA DIAGNOSTICS2016-09-09
HEPCHECK P214 NORMAL CONTROLACCRIVA DIAGNOSTICS2016-08-10
HEMOCHRON JR. DIRECTCHECK, PT ABNORMALACCRIVA DIAGNOSTICS2016-07-29
DIRECTCHECK, PT ABNORMALACCRIVA DIAGNOSTICS2016-06-20
DIRECTCHECK ACT+ ABNORMALACCRIVA DIAGNOSTICS2016-05-13
DIRECTCHECK QUALITY CONTROLACCRIVA DIAGNOSTICS2016-02-10
DIRECTCHECK QUALITY CONTROLACCRIVA DIAGNOSTICS2015-12-22
DIRECTCHECK QUALITY CONTROLACCRIVA DIAGNOSTICS2015-12-22
DRECTCHECK QUALITY CONTROL, NORMAL ACT+INTERNATIONAL TECHNIDYNE CORP.2015-09-15
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2015-07-15
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMALINTERNATIONAL TECHNIDYNE CORP.2015-06-23
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2015-06-11
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2015-04-23
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2015-04-03
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2015-03-18
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2015-02-20
ITC WHOLE BLOOD CONTROLINTERNATIONAL TECHNIDYNE CORP.2014-07-24
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORPORATION2014-04-22
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2014-03-12
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2014-02-28
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2014-01-18
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2013-12-27
GEM CHECK COAG WHOLE BLOOD CONTROLINTERNATIONAL TECHNIDYNE CORPORATION2013-12-19
GEM CHECK COAG WHOLE BLOOD CONTROLINTERNATIONAL TECHNIDYNE CORPORATION2013-12-19
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2013-09-03
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2013-06-18
DIRECT CHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2013-06-18
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2013-03-29
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2013-03-25
ITC WHOLE BLOOD CONTROLINTERNATIONAL TECHNIDYNE CORP.2013-02-05
DIRECT CHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORP.2012-11-12
DIRECTCHECK QUALITY CONTROLINTERNATIONAL TECHNIDYNE CORPORATION2012-09-26
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