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Glycosylated/glycated haemoglobin (cc)
Glycosylated/glycated haemoglobin (cc)
W01010214
278 devices
CAPILLARYS Hb A1c
Sebia
·
,
France
Class C
FDA 510(k)
K171861
Active
Cleared 7 Feb 2018
CE/IVDR
+1
authorizations
Glycated haemoglobin (HbA1c) Quantitative Test Kit(Dry Fluorescence Immunochrom…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Glycohemoglobin A 1C Reagent Kit
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Glycated Hemoglobin A1c (HPLC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hb NEXT T60 eluent C
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Glycohemoglobin A 1C Reagent Kit
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
HbA1c
Vitalscientific
·
,
France
Class B
CE/IVDR
GUDID
on market
Glycated albumin (GA) Assay Kit (Peroxidase Method)
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
Glycosylated Hemoglobin A1c (HbA1c)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Control
Shenzhen Dake Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Hemoglobin (A2/F/A1c) Test Reagent Kit (HPLC)
Labnovation Technologies, Inc.
·
,
China
IVD General
CE/IVDD
Glycosylated Haemoglobin (GHb)
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
Glycosylated Hemoglobin (HbA1c)Test Kit (Enzymatic)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Glycated Hemoglobin A1c (HPLC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Glycosylated Hemoglobin (HbA1c) Assay Kits （HPLC）
AILEX(Hunan)Medical Equipment Co., Ltd.
·
,
China
IVD General
CE/IVDD
Glycosylated Hemoglobin Test Kit
Changsha Sinocare Inc.
·
,
China
IVD General
CE/IVDD
Hemoglobin A1c Kit (Enzymatic Assay Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Glycated Hemoglobin A1c (HPLC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HbA1c Fast Test Kit (Immunofluorescence Assay)
Getein Biotech, Inc
·
,
China
Class C
CE/IVDR
Glycated Hemoglobin A1c (HPLC) Kit
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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