Manufacturer

Bioantibody Biotechnology

ChinaLegal entities : Bioantibody Biotechnology Co., Ltd.

Markets : Italy

Approvals : EU – class A

EU representative : Medunion S.L. (Spain)

16 categories, 61 models including 61 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
Virology - RT & POC - other	W0105099099	HSV 1/2 IgM/IgG Rapid Test Kit (Lateral Chromatography) 1 Tests/Kit98/79 HSV 1/2 IgM/IgG Rapid Test Kit (Lateral Chromatography) 25 Tests/Kit98/79 HSV 1/2 IgM/IgG Rapid Test Kit (Lateral Chromatography) 5 Tests/Kit98/79 Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 7 others Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 Mycoplasma Pneumoniae (MP) IgM/IgG Rapid Test Kit (Lateral Chromatography) 1 Tests/Kit98/79 Mycoplasma Pneumoniae (MP) IgM/IgG Rapid Test Kit (Lateral Chromatography) 25 Tests/Kit98/79 Mycoplasma Pneumoniae (MP) IgM/IgG Rapid Test Kit (Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 1 Tests/Kit98/79 Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 25 Tests/Kit98/79 4 others Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 5 Tests/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 1 other SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Gonorrhea Antigen Rapid Test Kit(Lateral Chromatography) 1 Test/Kit98/79 Gonorrhea Antigen Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 Gonorrhea Antigen Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H. Pylori Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 H. Pylori Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 H. Pylori Antigen Rapid Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79	– 98/79	EUDAMED record Report an error
Haematology reagents - other	W01030199	Hemoglobin (HB) Test Kit (Dry Chemistry) 1 Test/Kit98/79 Hemoglobin (HB) Test Kit (Dry Chemistry) 25 Tests/Kit98/79 Hemoglobin (HB) Test Kit (Dry Chemistry) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	HAV IgG/IgM Rapid Test Kit (Lateral Chromatography) 1 Tests/Kit98/79 HAV IgG/IgM Rapid Test Kit (Lateral Chromatography) 25 Tests/Kit98/79 HAV IgG/IgM Rapid Test Kit (Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 1 Test/Kit98/79 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 25 Tests/Kit98/79 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	SARS-CoV-2 & Influenza A/B & RSV & ADV Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Antigen Rapid Test Kit(Lateral Chromatography) 1 Test/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Handheld biochemical analyzer BK100 Handheld Biochemical Immunoassay Analyzer BK120	A IVDR	EUDAMED record Report an error
Semi-automated hematology analysers	W0202010202	Hematology Analyzer BK160	A IVDR	EUDAMED record Report an error
Urine strip readers	W020101020101	Handheld Urine Analyzer BK150	A IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.