Colorimetric Method, Gamma-glutamyl Transpeptidase
Clinical Chemistry · 21 CFR 862.1360
Recent MDR events
4 adverse event reports on file
- STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMPJan 31, 2013OtherSorin Group Deutschland1718850-2013-00004
- GAMMA-GLUTAMYL TRANSFERASE REAGENTDec 19, 2011MalfunctionBeckman Coulter, Inc.2050012-2011-08476
- GAMMA-GLUTAMYL TRANSFERASE REAGENTDec 19, 2011MalfunctionBeckman Coulter, Inc.2050012-2011-08478
- SYNCHRON® SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENTNov 15, 2011MalfunctionBeckman Coulter Inc.2050012-2011-07631
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
23 firms currently registered for this product code
Carolina Liquid Chemistries
Brea, CA, US
Abbott Laboratories
Lake Forest, IL, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
Abbott Gmbh
Wiesbaden Hesse, DE
Cliniqa Corporation
San Marcos, CA, US
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Fisher Diagnostics
MIDDLETOWN, VA, US
Alfa Wassermann
West Caldwell, NJ, US
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Beckman Coulter, Inc.
BREA, CA, US
Abbott Ireland Diagnostics Division
Longford, IE
Elhoda Trade And Supplies
Badr industerial city Al Qahirah, EG
Medica Corp.
BEDFORD, MA, US
Medicon Hellas Sa
GERAKAS Attiki, GR
Abbott Laboratories
Irving, TX, US
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Bialex Lab
Wichita Falls, TX, US
510(k) clearances
33 clearances for this product code
- Careside, Inc.Jul 1, 2002
K020486 · CARESIDE GGT
- Data Medical Associates, Inc.Jul 1, 1996
K961919 · DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
- Randox Laboratories, Ltd.Dec 3, 1992
K923509 · GAMMA-GT
- King Diagnostics, Inc.Sep 9, 1992
K923091 · KING DIAGNOSTICS GAMMA GT REAGENT
- Amresco, Inc.Feb 26, 1991
K905618 · GGT REAGENT
- Roche Diagnostic Systems, Inc.Oct 12, 1990
K903304 · ROCHE COBAS READY GGT REAGENT
- Elite Technology, Inc.Mar 29, 1990
K901090 · ELITECH GAMMA GT TEST KIT
- Wako Chemicals USA, Inc.Nov 8, 1989
K895984 · WAKO(TM) AUTOKIT GAMMA-GT