Manufacturer

Jiangxi CellGene Biotechnology

ChinaLegal entities : Jiangxi CellGene Biotechnology Co., Ltd.

Markets : Austria · Ireland

EU representative : Medunion S.L. (Spain)

4 categories, 74 models including 74 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Monoclonal antibodies for cell surface antigens - other	W0103080199	/98/79 APC E01030020198/79 APC E01030030198/79 APC E01030070198/79 APC E01030080198/79 50 others APC E01030090198/79 APC E01030120198/79 APC E01030130198/79 APC E01030190198/79 APC E01030350198/79 APC E01030390198/79 APC E01030480198/79 APC E01030510198/79 APC E01030530198/79 APC E01030560198/79 APC E01030570198/79 APC E01030590198/79 APC E01030670198/79 APC E01030700198/79 APC E01030720198/79 APC E01030760198/79 APC E01030800198/79 APC E01030810198/79 APC E01030820198/79 APC E01030840198/79 APC E01030870198/79 APC E01030880198/79 APC E01030890198/79 APC E01030910198/79 APC E01030930198/79 APC E01030940198/79 APC E01030980198/79 APC E01031030198/79 APC E01031040198/79 APC E01031050198/79 APC E01031210198/79 APC E01031410198/79 APC E01032480198/79 APC-Cy738 refs98/79 CD4 CountPro Kit 20tests98/79 CD4 CountPro Kit 20tests/kit9 refs98/79 CD4 CountPro Kit 25 tests/kit4 refs98/79 CD4 CountPro Kit 50 tests/kit4 refs98/79 CD4 CountPro Kit 50tests/kit10 refs98/79 FITC69 refs98/79 PD-1 QuantPlus Kit 100 tests/kit3 refs98/79 PD-1 QuantPlus Kit 25 tests/kit3 refs98/79 PE39 refs98/79 PE-Cy738 refs98/79 PerCP38 refs98/79 PerCP-Cy5.538 refs98/79 TBNK Kit 20tests/kit2 refs98/79 TBNK Kit 50tests/kit2 refs98/79 TBNK Kit with Absolute Counting (Lyophilized Pellets) 25tests/kit2 refs98/79 TBNK Kit with Absolute Counting (Lyophilized Pellets) 50tests/kit98/79	– 98/79	EUDAMED record Report an error
Lymphokines /immunmodulators - other	W01030699	23mL/kit98/79 Cytokines Multiplex Detection Kit 100tests/kit8 refs98/79 Cytokines Multiplex Detection Kit 12-plexⅡ 200tests/kit98/79 Cytokines Multiplex Detection Kit 200tests/kit7 refs98/79 Cytokines Multiplex Detection Kit 20tests/kit7 refs98/79 11 others Cytokines Multiplex Detection Kit 23mL/kit7 refs98/79 Cytokines Multiplex Detection Kit 40tests/kit8 refs98/79 Cytokines Multiplex Detection Kit 6-plexⅡ 20tests/kit98/79 Cytokines Multiplex Detection Kit 96tests/kit8 refs98/79 Soluble Inflammatory Factors Kit 100tests/kit98/79 Soluble Inflammatory Factors Kit 20tests/kit98/79 Tumor Companion Kit 100tests/kit4 refs98/79 Tumor Companion Kit 200tests/kit4 refs98/79 Tumor Companion Kit 20tests/kit3 refs98/79 Tumor Companion Kit 3-plex A 20tests/kit98/79 Tumor Companion Kit 50tests/kit4 refs98/79	– 98/79	EUDAMED record Report an error
Reagents for flow cytometry - other	W0103080699	Absolute Counting Tubes (Lyophilized Pellets) 25tests/kit98/79 Absolute Counting Tubes (Lyophilized Pellets) 50tests/kit98/79	– 98/79	EUDAMED record Report an error
Antibodies for lymphocyte subtyping	W0103080106	TBNK Kit with Absolute Counting (Lyophilized Pellets) 50tests/kit98/79	– 98/79	EUDAMED record Report an error

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