GFO

Product Code: GFO


Products Classified as GFO

2247Activated Partial ThromboplastinPartial Thromboplastin Time Tests.

Total Product Life Cycle (TPLC) Devices

2247Activated Partial ThromboplastinPartial Thromboplastin Time Tests.

FDA Consensus Standards

Activated Partial Thromboplastin [37753]21 CFR §864.7925 🔎
Activated Partial Thromboplastin [21764]21 CFR §864.7925 🔎
Activated Partial Thromboplastin [27770]21 CFR §864.7925 🔎
Activated Partial Thromboplastin [32362]21 CFR §864.7925 🔎

Pre-market Notifications for GFO

K193556Cryocheck Hex LAPrecision BioLogic
K160445HemosIL Silica Clotting TimeINSTRUMENTATION LABORATORY CO.
K060688HEMOSIL SYNTHASILINSTRUMENTATION LABORATORY CO.
K053111STA-CEPHASCREEN KITDIAGNOSTICA STAGO, INC.
K050221HEMOSIL SILICA CLOTTING TIMEINSTRUMENTATION LABORATORY CO.
K022021VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTVITAL SCIENTIFIC N.V.
K014028CARESIDE APTTCARESIDE HEMOTOLOGY, INC.
K014008HEMOCHRON JR. CITRATE APTT CUVETTEITC, INC.
K992711SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094SIGMA DIAGNOSTICS, INC.
K992712SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334SIGMA DIAGNOSTICS, INC.
K973306IL TEST APTT-SPINSTRUMENTATION LABORATORY CO.
K972831HEMOCHRON CITRATE APTTINTERNATIONAL TECHNIDYNE CORP.
K961892SPECKTIN-LA TEST SETANALYTICAL CONTROL SYSTEMS, INC.
K955638SYNTHAFAX APTT REAGENTORTHO DIAGNOSTIC SYSTEMS, INC.
K955450PATHROMTIN SLBEHRING DIAGNOSTICS, INC.

Global Unique Device Identification Database

10627944000100Activated Partial Thromboplastin
10627944000094Activated Partial Thromboplastin
00627944000059Activated Partial Thromboplastin
00627944000042Activated Partial Thromboplastin
00845275000771Activated Partial Thromboplastin
00845275000764Activated Partial Thromboplastin
00845275000665Activated Partial Thromboplastin
00845275000641Activated Partial Thromboplastin
00845275000511Activated Partial Thromboplastin
00842768007538ACTIVATED PARTIAL THROMBOPLASTIN
00842768007521ACTIVATED PARTIAL THROMBOPLASTIN
00842768003851ACTIVATED PARTIAL THROMBOPLASTIN
00842768003837ACTIVATED PARTIAL THROMBOPLASTIN
05391521420305Activated Partial Thromboplastin
05391521420299Activated Partial Thromboplastin

Maude Adverse Events

PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-09-06
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-10-26
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-10-26
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-10-26
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-10-26
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-09-29
PATHROMTIN? SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-09-25
DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-08-11
DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-08-11
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-08-11
DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-08-11
DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-08-11
DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-08-11
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-08-11
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-07-20
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-07-20
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-07-20
DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-07-03
DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-07-03
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-05-15
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2017-04-25
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-03-24
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-03-10
PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-03-10
DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2016-02-11
DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2016-02-11
DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2016-02-11
DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2015-04-09
DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2015-04-09
DADE PATHROMTIN SLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2014-08-19
HEMOCHRON JR. CITRATE APTT CUVETTEINTERNATIONAL TECHNIDYNE CORP.2014-02-04
HEMOCHRON JR. CITRATE APTT CUVETTEINTERNATIONAL TECHNIDYNE CORP2013-11-14
HEMOCHRON JR. CITRATE APTT CUVETTEINTERNATIONAL TECHNIDYNE CORP2013-11-14
HEMOCHRON JR. CITRATE APTT CUVETTEINTERNATIONAL TECHNIDYNE CORP.2013-11-05
HEMOCHRON JR PT CUVETTEITC2011-10-03
HEMOCHRON JR PT CUVETTEITC2011-08-23
HEMOCHRON JR PT CUVETTEITC2011-08-23
HEMOCHRON JR PT CUVETTEITC2011-08-12
HEMOCHRON JR PT CUVETTEITC2011-08-12
HEMOCHRON JR PT CUVETTEITC, INC2011-08-05
BECKMAN COULTER HEMOSIL SILICA CLOTTING TIME2011-02-23
SYNTHAFAX APTT REAGENTORTHO CLINICAL DIAGNOSTICS INC. HEMOLIANCE DIV1999-05-18
ORTHO BRAIN THROMBOPLASTINORTHO-CLINICAL DIAGNOSTICS1998-07-15
ORTHO BRAIN THROMBOPLASTINORTHO-CLINICAL DIAGNOSTICS1998-07-13
ORTHO BRAIN THROMBOPLASTINORTHO-CLINICAL DIAGNOSTICS1998-07-13
ORTHO BRAIN THROMBOPLASTINORTHO-CLINICAL DIAGNOSTICS1998-07-13
ORTHO BRAIN THROMBOPLASTINORTHO-CLINICAL DIAGNOSTICS1998-07-13
ORTHO BRAIN THROMBOPLASTINORTHO-CLINICAL DIAGNOSTICS1998-07-13
ORTHO BRAIN THROMBOPLASTINORTHO-CLINICAL DIAGNOSTICS, INC.1998-07-09
HEMOCHRON JR.ITC1998-01-12
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.