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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Anemia related / vitamin tests
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Anemia
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Erythropoietin
Erythropoietin
W0102070101
8 devices
Devices
Access EPO (Reagent Pack)
Beckman Coulter, Inc.
·
,
US
Class C
FDA 510(k)
K240182
Active
Cleared 22 Apr 2024
CE/IVDR
+1
authorizations
Immulite 2000 Epo
Siemens Healthcare Diagnostics Products Limited
·
,
GB
Class B
CE/IVDR
EPO (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
EPO (Erythropoietin) ELISA
Biomerica, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
EPO (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
EPO (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
CN
IVD General
CE/MDR
Erythropoietin ELISA
Ibl International GmbH
·
,
DE
IVD General
CE/IVDD
EPO (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
CN
IVD General
CE/MDR
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