GJS

Product Code: GJS


Products Classified as GJS

2299Test, Time, ProthrombinProthrombin Time Test.

Total Product Life Cycle (TPLC) Devices

2299Test, Time, ProthrombinProthrombin Time Test.

FDA Consensus Standards

Test, Time, Prothrombin [37753]21 CFR §864.7750 🔎
Test, Time, Prothrombin [21764]21 CFR §864.7750 🔎
Test, Time, Prothrombin [27770]21 CFR §864.7750 🔎
Test, Time, Prothrombin [32362]21 CFR §864.7750 🔎
Test, Time, Prothrombin [35832]21 CFR §864.7750 🔎

Pre-market Notifications for GJS

K212779Coag-Sense Prothrombin (PT) / INR Monitoring System For Patient Self-TestingCoaguSense, Inc.
K201185MicroINR SystemILine Microsystems S.L.
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoaguSense, Inc.
K180780MicroINR SystemILine Microsystems S.L.
K180693CoaguChek XS Pro SystemRoche Diagnostics
K180684CoaguChek XS Plus SystemRoche Diagnostics
K170960CoaguChek Vantus SystemRoche Diagnostics
K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSIEMENS HEALTHCARE DIAGNOSTICS
K132722HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)INSTRUMENTATION LABORATORY CO.
K122584HEMOSIL READIPLAS TININSTRUMENTATION LABORATORY CO.
K110212INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIPALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
K093460COAGUCHEK XS PRO SYSTEMRoche Diagnostics
K093243COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEMCOAGUSENSE, INC
K092987INRATIO/INRATIO2 TEST STRIPSBIOSITE INCORPORATED
K092940COAGUCHEK XS PLUS PST SYSTEMROCHE DIAGNOSTICS CORP.

Global Unique Device Identification Database

10385480347171TEST, TIME, PROTHROMBIN
10385480340813TEST, TIME, PROTHROMBIN
00365702700499Test, Time, Prothrombin
00365702398108TEST, TIME, PROTHROMBIN
00365702164109TEST, TIME, PROTHROMBIN
00365702128101TEST, TIME, PROTHROMBIN
00365702127104TEST, TIME, PROTHROMBIN
00365702126107TEST, TIME, PROTHROMBIN
00365702125100TEST, TIME, PROTHROMBIN
00630414034348TEST, TIME, PROTHROMBIN
00630414023496TEST, TIME, PROTHROMBIN
00630414023489TEST, TIME, PROTHROMBIN
00630414023472TEST, TIME, PROTHROMBIN
00630414023465TEST, TIME, PROTHROMBIN
00630414023441TEST, TIME, PROTHROMBIN

Maude Adverse Events

DADE INNOVINSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2020-03-31
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-27
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-27
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-26
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-26
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-26
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-26
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-26
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-26
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-25
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-25
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-25
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-25
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-25
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK PT 2X24 TESTROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-24
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-23
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-23
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-23
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-23
TEST, TIME, PROTHROMBINCOAGUSENSE, INC2020-03-23
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-23
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-23
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-20
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-20
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-20
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-20
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-20
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-19
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-18
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-18
COAGUCHEK ? XS SYSTEMROCHE DIAGNOSTICS2020-03-18
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