GIS

Product Code: GIS

Products Classified as GIS

2286

Test, Fibrinogen

Fibrinogen Determination System.

Total Product Life Cycle (TPLC) Devices

2286

Test, Fibrinogen

Fibrinogen Determination System.

FDA Consensus Standards

• Test, Fibrinogen [12507]: 21 CFR §864.7340 🔎

Pre-market Notifications for GIS

K143470	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set	DIAZYME LABORATORIES
K042919	FIBROTEK FIB	R2 DIAGNOSTICS, INC.
K993482	K-ASSAY FIBRINOGEN	KAMIYA BIOMEDICAL CO.
K963902	QUANTITATIVE FIBRINOGEN ASSAY	ORTHO DIAGNOSTIC SYSTEMS, INC.
K941001	ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT	DIAGNOSTIC SPECIALTIES
K925494	BIOMERIEUX HEMOLAB FIBRINOMAT	BIOMERIEUX VITEK, INC.
K923921	IL TEST PT FIBRINOGEN HS	INSTRUMENTATION LABORATORY CO.
K913061	FIBRINOGEN DETERMINATION KIT	SIGMA DIAGNOSTICS, INC.
K910636	ABS CADKIT	PANBIO, INC.
K903874	FIBRINOTEST(TM) - FIBRINOGEN ASSAY	HAEMACHEM, INC.
K881685	FIBRINOGENTEST-O	DIATECH, INC.
K881150	KINETIC FIBRINOGEN ASSAY	BIO/DATA CORP.
K781880	ASSAY KIT, THROMBO-SCREEN	PACIFIC HEMOSTASIS

Global Unique Device Identification Database

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

Maude Adverse Events

INRATIO TEST KIT	ALERE SAN DIEGO	2019-09-19
INRATIO	HEMOSENSE, INC.	2007-01-19
INRATIO	HEMOSENSE, INC.	2007-01-09
INRATIO	HEMOSENSE, INC.	2007-01-09
INRATIO	HEMOSENSE, INC.	2007-01-09
INRATIO	HEMOSENSE, INC.	2007-01-09
INRATIO	HEMOSENSE, INC.	2007-01-09
INRATIO	HEMOSENSE, INC.	2007-01-09
INRATIO	HEMOSENSE, INC.	2007-01-09
INRATIO	HEMOSENSE, INC.	2006-09-08
INRATIO	HEMOSENSE, INC.	2006-09-08
INRATIO	HEMOSENSE, INC.	2006-09-08
INRATIO	HEMOSENSE, INC.	2006-09-08
INRATIO	HEMOSENSE, INC.	2006-08-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-05-03
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-26
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-20
INRATIO	HEMOSENSE, INC.	2006-04-13
INRATIO	HEMOSENSE, INC.	2006-04-13
INRATIO	HEMOSENSE, INC.	2006-04-06