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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VZV IgM ELISA 96 Well Kit, Catalog Number: VZ082M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code GQX·August 27, 2008
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GQX·May 29, 2012
Antiserum, Cf, Varicella-Zoster
FDA classification
FDA Class 2
·Antiserum, Cf, Varicella-Zoster
GCX Corporation
FDA registration
GCX Corporation·3 products·🇺🇸 United States
ATHENA GTX
FDA registration
ATHENA GTX·12 products·🇺🇸 United States
GCX CORPORATION
FDA registration
GCX CORPORATION·1 product·🇺🇸 United States
GLX MEDICAL DEVICES COMPANY LIMITED
FDA registration
GLX MEDICAL DEVICES COMPANY LIMITED·15 products·🇻🇳 Vietnam
GBX Twin Pack
FDA UDI
CARESTREAM HEALTH, INC.·40889975158613·GBX TWIN PACK, 10L
GBX Twin Pack
FDA UDI
CARESTREAM HEALTH, INC.·40889971901855·GBX Twin Pack - 2x1GL
G3 X APAP
FDA UDI
BMC Medical Co., Ltd.·06948538363553·G3 X APAP
G3 X APAP
FDA UDI
BMC Medical Co., Ltd.·06948538363560·G3 X APAP
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945000001120·Wireless Patient Monitor
WiCap
FDA UDI
ATHENA GTX, INC.·B3945000016010·Patient Monitor
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945700025040·BP Extension Hose-4 ft
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945700047010·miniCap Mainstream
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945700025020·BP Extension Hose-2 ft
Athena GTX Device Management Suite (ADMS) Software
FDA UDI
ATHENA GTX, INC.·B3943900008000·Athena GTX Device Management Suite - PC
TACVAC
FDA UDI
ATHENA GTX, INC.·B3945100006010·Portable Battery Powered Suction Device
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945700025030·BP Extension Hose-3 ft
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945000025030·Carry case/Charger for 10 WVSMs - Orange