GIS

Product Code: GIS


Products Classified as GIS

2286Test, FibrinogenFibrinogen Determination System.

Total Product Life Cycle (TPLC) Devices

2286Test, FibrinogenFibrinogen Determination System.

FDA Consensus Standards

Test, Fibrinogen [12507]21 CFR §864.7340 🔎

Pre-market Notifications for GIS

K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDIAZYME LABORATORIES
K042919FIBROTEK FIBR2 DIAGNOSTICS, INC.
K993482K-ASSAY FIBRINOGENKAMIYA BIOMEDICAL CO.
K963902QUANTITATIVE FIBRINOGEN ASSAYORTHO DIAGNOSTIC SYSTEMS, INC.
K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDIAGNOSTIC SPECIALTIES
K925494BIOMERIEUX HEMOLAB FIBRINOMATBIOMERIEUX VITEK, INC.
K923921IL TEST PT FIBRINOGEN HSINSTRUMENTATION LABORATORY CO.
K913061FIBRINOGEN DETERMINATION KITSIGMA DIAGNOSTICS, INC.
K910636ABS CADKITPANBIO, INC.
K903874FIBRINOTEST(TM) - FIBRINOGEN ASSAYHAEMACHEM, INC.
K881685FIBRINOGENTEST-ODIATECH, INC.
K881150KINETIC FIBRINOGEN ASSAYBIO/DATA CORP.
K781880ASSAY KIT, THROMBO-SCREENPACIFIC HEMOSTASIS

Global Unique Device Identification Database

00816426021082Test, Fibrinogen
00816426021075Test, Fibrinogen
00816426020658Test, Fibrinogen
00816426020351Test, Fibrinogen
00816426020214Test, Fibrinogen
00845275000856Test, Fibrinogen
00845275000849Test, Fibrinogen
00845275000825Test, Fibrinogen
00845275000627Test, Fibrinogen
00845275000597Test, Fibrinogen
00845275000580Test, Fibrinogen
08426950573500TEST, FIBRINOGEN
08426950573494TEST, FIBRINOGEN

Maude Adverse Events

INRATIO TEST KITALERE SAN DIEGO2019-09-19
INRATIOHEMOSENSE, INC.2007-01-19
INRATIOHEMOSENSE, INC.2007-01-09
INRATIOHEMOSENSE, INC.2007-01-09
INRATIOHEMOSENSE, INC.2007-01-09
INRATIOHEMOSENSE, INC.2007-01-09
INRATIOHEMOSENSE, INC.2007-01-09
INRATIOHEMOSENSE, INC.2007-01-09
INRATIOHEMOSENSE, INC.2007-01-09
INRATIOHEMOSENSE, INC.2006-09-08
INRATIOHEMOSENSE, INC.2006-09-08
INRATIOHEMOSENSE, INC.2006-09-08
INRATIOHEMOSENSE, INC.2006-09-08
INRATIOHEMOSENSE, INC.2006-08-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-05-03
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-26
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-20
INRATIOHEMOSENSE, INC.2006-04-13
INRATIOHEMOSENSE, INC.2006-04-13
INRATIOHEMOSENSE, INC.2006-04-06

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