Manufacturer

Isiabio

ChinaLegal entities : Chongqing iSIA BIO-Technology Co., Ltd.

First countries of placing on the market declared in EUDAMED : Czechia, Spain

EU representative : CMC Medical Devices & Drugs SL (Spain)

24 categories, 39 models including 39 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
H. pylori antibody assays	W0105010402	H.Pylori IgG-CLIA98/79 Helicobacter Pylori (H.Pylori) antibody Rapid Test Kit (QDs Immunofluorescence Method) HP Ab-QD98/79 Helicobacter Pylori (H.Pylori) Typing Test Kit (QDs Immunofluorescence Method) H.Pylori Typing-QD98/79 Helicobacter Pylori (H.Pylori) Typing Test kit (QDs Immunofluorescence Method) HP Typing-QD98/79 HP IgG Test Kit (CLIA Method)98/79 1 other HP Typing Test Kit (CLIA Method)98/79	– 98/79	EUDAMED record Report an error
Other virology controls - inf.imm.	W0105080804	Control For Adenovirus antigen ADV-CONTROL98/79 Control For Flu A/B antigen98/79 Control For Respiratory Syncytial Virus (RSV) antigen 057Z98/79 Control For SARS-CoV-2 Antigen SARS-CoV-2-CONTROL98/79	– 98/79	EUDAMED record Report an error
Aspergillus	W0105060301	Aspergillus Galactomannan Rapid Test Kit (QDs Immunofluorescence Method) Aspergillus GM-QD98/79 Aspergillus IgG Antibody Rapid Test Kit (QDs Immunofluorescence Method) Aspergillus IgG-QD98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-dimer Rapid Test Kit (QDs Immunofluorescence Method) D-dimer-QD98/79 D-Dimer Test Kit (CLIA Method)98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue Virus IgM/IgG Test Kit（FIA） DENV IgM/IgG-FIA98/79 Dengue Virus NS1 Test Kit（FIA） DENV NS1-FIA98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Helicobacter Pylori (H.Pylori) Antigen Rapid Test Kit (QDs Immunofluorescence Method) H.Pylori Ag-QD98/79 Helicobacter Pylori (H.Pylori) Antigen Rapid Test Kit (QDs Immunofluorescence Method) HP Ag-QD98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin 6 (IL-6) Rapid Test Kit (QDs Immunofluorescence Method) IL-6-QD98/79 Interleukin 6 (IL-6) Test Kit (CLIA Method) IL-6-CLIA98/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	Fluorescent Immuno analyzer AFS-1000 Fluorescent Immunoassay Analyzer	A IVDR	EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex	W0103020305	Plasmin-α2-Plasmin Inhibitor Complex (PIC) Test Kit (CLIA Method)98/79 Thrombin-Antithrombin Ⅲ complex (TAT) Test Kit (CLIA Method)98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Antigen Rapid Test Kit (QDs Immunofluorescence Method) ADV-QD2 refs98/79	– 98/79	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	Control For Helicobacter Pylori (H.Pylori) H.Pylori Ag-CONTROL 099Z98/79	– 98/79	EUDAMED record Report an error
Candida albicans	W0105060302	Candida IgG Antibody Rapid Test Kit (QDs Immunofluorescence Method) Candida IgG-QD98/79	– 98/79	EUDAMED record Report an error
Coagulation inhibitors - other	W0103020699	Thrombomodulin (TM) Test Kit (CLIA Method)98/79	– 98/79	EUDAMED record Report an error
Coronavirus ag	W0105041101	SARS-CoV-2 Antigen Rapid Test Kit (QDs Immunofluorescence Method) SARS-CoV-2-QD98/79	– 98/79	EUDAMED record Report an error
Cryptococcus	W0105060303	Cryptococcus Antigen Rapid Test Kit (QDs Immunofluorescence Method) Cryptococcus-QD98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Fibrinogen Degradation Product (FDP) Test Kit (CLIA Method)98/79	– 98/79	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	Control For D-Dimer 005Z98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza	W0105040604	Influenza A/B (Flu A/B) virus antigen Rapid Test Kit (QDs Immunofluorescence Method) Flu A/B-QD98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Influenza A/B (Flu A/B) virus antigen Rapid Test Kit (QDs Immunofluorescence Method) Flu A/B-QD98/79	– 98/79	EUDAMED record Report an error
Mycology controls - inf.imm.	W0105080806	Control For Cryptococcus 048Z98/79	– 98/79	EUDAMED record Report an error
Mycology immunoassays - other	W0105060399	Candida Mannan Rapid Test Kit (QDs Immunofluorescence Method) Candida Mannan-QD98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	Respiratory Syncytial Virus (RSV) Antigen Rapid Test Kit (QDs Immunofluorescence Method) RSV-QD2 refs98/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	Thrombin-Antithrombin Ⅲ complex (TAT) Test Kit (CLIA Method)98/79	– 98/79	EUDAMED record Report an error
Tissue plasminogen activator	W0103020507	Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (tPAIC) Test Kit (CLIA Method)98/79	– 98/79	EUDAMED record Report an error

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