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In vitro diagnostic medical devices
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Reagents
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Clinical chemistry
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Controls/standards/calibrators clinical chemistry
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Multicomponent controls (clinical chemistry)
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Unassayed multicomponent controls (cc)
Unassayed multicomponent controls (cc)
W0101050102
34 devices
Devices
KEYU Urine Sediment Analyzer Quality Control
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
Liquid Immunoassay Control - Level 2 (IA CONTROL 2)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
KEYU Urine Sediment QC
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
Xanthochromia Positive Control (Xanthochromia Control +)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
KEYU Urine Sediment Analyzer Quality Control
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
KEYU Urine Chemistry QC
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
Liquid Chemistry Premium Plus - Level 3 (Liq Chem Premium Plus 3)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
Liquid Chemistry Premium Plus - Level 1 (Liq Chem Premium Plus 1)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
KEYU Dry Chemistry Urine analysis Control
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
Custom Liquid Chemistry Control Level 1
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
KEYU Urine Formed Element QC
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
KEYU Urine Sediment Analyzer Quality Control
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/MDR
KEYU Urine Chemistry Analysis QC
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
KEYU Urine Formed Element QC
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
KEYU Urine Formed Element QC
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
Custom Liquid Chemistry Control Level 2
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
KEYU Urine Chemistry QC
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
Human Precision Control - Level 3 (Hum Prec Control 3)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
Custom Liquid Chemistry Control Level 3
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
Serum Indices (Serum Indices)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
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