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Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JQA·November 23, 2020

ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JQA·November 23, 2020

Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes

FDA classification
FDA Class 1 ·Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes

AIA-900

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code KHO·August 31, 2018

CQA "StarTrack"

FDA UDI
IBA Dosimetry GmbH·EIBAE30350100·CQA "StarTrack" calibrated

GUM®

FDA UDI
SUNSTAR AMERICAS, INC.·00070942751469·RED-COTE® Plaque Disclosing Tablets

Oxygen Concentrator (J5A)

FDA 510(k)
FDA Class 2 ·Anesthesiology

CURT G. JOA, INC.

FDA registration
CURT G. JOA, INC.·2 products·🇺🇸 United States

Image Quality Analyzer (IQA)

FDA 510(k)
FDA Class 2 ·Radiology

NEURO DQA PHANTOM GEL

FDA UDI
INSIGHTEC LTD·07290015461207·DQA phantom (tissue mimic) gel for calibration ...

Neurolyser XR DQA Assembly

FDA UDI
FUSMobile LTD·07290019747031·

Exablate DQA Phantom Gel

FDA UDI
INSIGHTEC LTD·07290015461214·Tissue mimic phantom gel for DQA for Body appli...

J2A SLA Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

Gafchromic™

FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065949·Blood Irradiation Indicator

Gafchromic™

FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065093·

SHIAN JIA MEEI ENTERPRISE CO., LTD.

FDA registration
SHIAN JIA MEEI ENTERPRISE CO., LTD.·1 product·🇹🇼 Taiwan

Shen Jia Yi Optical (Shenzhen) Ltd

FDA registration
Shen Jia Yi Optical (Shenzhen) Ltd·1 product·🇨🇳 China

DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD

FDA registration
DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD·4 products·🇨🇳 China

Jiangmen Jia Mei Medical Products Co., Ltd.

FDA registration
Jiangmen Jia Mei Medical Products Co., Ltd.·8 products·🇨🇳 China

SU ZHOU HUI JIA TEXTILES CORPORATION LIMITED

FDA registration
SU ZHOU HUI JIA TEXTILES CORPORATION LIMITED·2 products·🇨🇳 China