Manufacturer

Beijing Applied Biological Technologies

ChinaLegal entities : Beijing Applied Biological Technologies Co., Ltd.

Markets : Belgium · Germany · Spain

Approvals : EU – class A

EU representative : Luxus Lebenswelt GmbH (Germany)

66 categories, 129 models including 129 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
Respiratory tract infections - multiplex NA reagents	W0105070503	Duplex Real-Time PCR Detection Kit for Influenza Virus A and Influenza Virus B3 refs98/79 Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Pertussis2 refs98/79 Duplex Real-Time PCR Detection Kit for Mycoplasma pneumoniae and Legionella pneumophila98/79 Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Influenza Viruse A and Influenza Viruse B98/79 Duplex Real-Time PCR Kit for Detection of Mycoplasma Pneumoniae and Bordetella Pertussis98/79 8 others Multiplex Real-Time PCR Detection Kit for 17 Species of Respiratory Pathogens3 refs98/79 Multiplex Real-Time PCR Detection Kit for 6 Respiratory Viruses98/79 Triplex Real-Time PCR Detection Kit for Human metapneumovirus/Human rhinovirus /Human bocavirus98/79 Triplex Real-Time PCR Detection Kit for Klebsiella pneumoniae/Pseudomonas aeruginosa/Acinetobacter baumannii98/79 Triplex Real-time PCR Detection Kit for Middle East Respiratory Syndrome (MERS)98/79 Triplex Real-Time PCR Detection Kit for Staphylococcus aureus/Enterococcus faecalis/Enterococcus faecium98/79 Triplex Real-Time PCR Detection Kit for Streptococcus pneumonia, Haemophilus influenza and Moraxella catarrhala98/79 Triplex Real-Time PCR Kit for Detection of Escherichia coli/Enterobacter cloacae complex/ Burkholderia cepacia complex98/79	– 98/79	EUDAMED record Report an error
Coronavirus ag	W0105041101	2019-nCoV Antigen Rapid Test Cassette28 refs98/79 2019-nCoV Antigen Rapid Test Cassette Anterior Nasal Swab98/79 2019-nCoV Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab98/79 2019-nCoV Antigen Rapid Test Cassette Saliva98/79 6 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method)116 refs98/79 4 others SARS-CoV-2 Antigen Rapid Test Cassette4 refs98/79 SARS-CoV-2 Antigen Rapid Test Cassette Anterior Nasal Swab98/79 SARS-CoV-2 Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab98/79 SARS-CoV-2 Antigen Rapid Test Cassette Saliva98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	ARMS-PCR Detection Kit for 2019-nCoV HV69-70del and N501Y mutation98/79 ARMS-PCR Detection Kit for SARS-CoV-2 L452R and E484Q Mutation98/79 ARMS-PCR Diagnostic Detection Kit for 2019-nCoV HV69-70del and N501Y mutation98/79 Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N5 refs98/79 Duplex Real-Time PCR Kit for Rapid Detection of 2019-nCoV ORF1ab/N gene98/79 1 other Multiple Real-Time PCR Kit for Detection of 2019-nCoV6 refs98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Multiplex PCR Detection Kit for 5 Diarrheagenic Escherichia coli2 refs98/79 Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogenic E. coli (GB.V.)(Freeze-dried Type)2 refs98/79 Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses98/79 Triple Real-time PCR Detection Kit for Salmonella / Shigella / Vibrio Cholerae98/79 Triplex Real-time PCR Detection Kit for Group A Rotavirus / Norovirus GI / Norovirus GII98/79 1 other Triplex Real-Time PCR Kit for Detection of Norovirus, Rotavirus and Adenovirus98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Bacterial DNA Extraction Kit Nucleic Acid Extraction Kit CN8033 Nucleic Acid Extraction Kit CN8043 Sample Release Reagent B2150 Sample Release Reagent CN8063 1 other Sample Release Reagent CN8073	A IVDR	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus 712 refs98/79 Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Coxsackievirus A16 and Human Enterovirus 7198/79 Influenza A / B / Parainfluenza virus Antigen Rapid Test Cassette (Colloidal Gold Method)98/79 Real-time PCR Detection Kit for Coxsackievirus A16, Enterovirus 71 and Enterovirus98/79 Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Plasmodium Falciparum/Plasmodium Vivax Antigen Rapid Test Cassette (Colloidal Gold Method)98/79 Real-time PCR Detection Kit for Plasmodium Malariae98/79 Real-time PCR Detection Kit for Plasmodium Ovale98/79 Real-time PCR Detection Kit for Plasmodium Vivax98/79 Real-Time PCR Detection Kit for Universal Plasmodium Falciparum98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 and Influenza Viruses A/B98/79 Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N and Influenza Viruses A/B3 refs98/79 Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2, Influenza Viruses A/B and Respiratory Syncytial Virus98/79 Quadruplex Real-Time PCR Diagnostic Kit for Rapid Detection of 2019-nCoV and Influenza Viruses A/B98/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	"Quadruple Real-time PCR Detection Kit for Universal Type Vibrio Cholerae / O1 Group / O139 Group / CTX Gene "98/79 Real-time PCR Detection Kit for O1group vibrio cholerae98/79 Real-time PCR Detection Kit for Vibrio Cholerae Nucleic Acid98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Quadruplex Real-time PCR Detection Kit for Dengue Fever Type I / II / III / IV98/79 Real-time PCR Detection Kit for Dengue Type I98/79 Real-Time PCR Detection Kit for Universal Dengue98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Multiple Real-Time PCR Detection Kit for Norovirus GI/GII2 refs98/79 Real-time PCR Detection Kit for Norovirus GI98/79 Real-time PCR Detection Kit for Norovirus GII98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	ABT-24 Automatic Nucleic Acid Extraction and Real-Time PCR System ABT-24 X-Poche 162 refs	A IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Real-time PCR Detection Kit for Coxsackievirus A6 and Coxsackievirus A1098/79 Real-time PCR Detection Kit for Rift Valley Fever98/79 Real-time PCR Detection Kit for Yellow Fever98/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Real-time PCR Detection Kit for Enteral Adenovirus98/79 Real-Time PCR Diagnostic Kit for Rapid Detection of Respiratory Adenovirus98/79	– 98/79	EUDAMED record Report an error
Campylobacter detection by NA reagents	W0105011402	Duplex Real-time PCR Detection Kit for Campylobacter Jejuni and Campylobacter coli2 refs98/79 Triplex Real-time PCR Diagnostic Kit for Rapid Detection of C. jejuni, C. coli and C. lari98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses98/79 SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	Real-Time PCR Detection Kit for Enterovirus98/79 Real-Time PCR Diagnostic Kit for Human Enterovirus 71 (EV71) (TaqMan probe method)98/79	– 98/79	EUDAMED record Report an error
H. pylori reagents - other	W0105010499	Helicobacter Pylori (HP) Typing test cassette (Lateral Flow Method)98/79 Multiple Real-Time PCR Detection Kit for Helicobacter Pylori Resistance Gene2 refs98/79	– 98/79	EUDAMED record Report an error
Other coronavirus reagents	W0105041199	SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Quadruplex Real-time PCR Detection Kit for Dengue / Marburg / Rift Valley Fever / Lassa98/79 Triplex Real-time PCR Detection Kit for Yellow Fever/Zika/Chikungunya98/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Vibrio Cholerae O1/O139 Antigens Rapid Test Cassette(Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Bocavirus - NA reagents	W0105040518	Real-time PCR Detection Kit for Bocavirus98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Duplex Real-time PCR Detection Kit for Bordetella Pertussis2 refs98/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya Virus IgM Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	Real-time PCR Detection Kit for Chikungunya98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibodies - total	W0105041102	2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method)7 refs98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Antigen Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Diphtheria (corynebacterium d.) - NA reagents	W0105011608	Duplex Real-Time PCR Diagnostic Kit for Identifying Tox Virulence Gene in Corynebacterium Diphtheriae(TaqMan probe method)98/79	– 98/79	EUDAMED record Report an error
DNA genomic preparation devices	W02050106	MagiCube 48	A IVDR	EUDAMED record Report an error
E. coli detection by NA reagents	W0105011503	Real-time PCR Diagnostic Kit for Rapid Detection of Enterohemorrhagic E. coli (EHEC)98/79	– 98/79	EUDAMED record Report an error
Ebola (filovirus) - NA reagents	W0105040528	Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Ebola-Zaire2 refs98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Fibrinogen/Fibrin Degradation Products (PDF) rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	PCR-based Neisseria Gonorrhoeae Test Kit (Fluorometric PCR)98/79	– 98/79	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex assays	W0105070203	Triplex Real-Time PCR Kit for Detection of Aspergillus, Cryptococcus neoformans and Pneumocystis98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Helicobacter Pylori Antigen Rapid Test Cassette (Lateral Flow Method)98/79	– 98/79	EUDAMED record Report an error
Hantavirus / bunyavirus - NA reagents	W0105040514	Real-time PCR Detection Kit for Novel Bunyavirus98/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Hepatitis a virus - NA reagents	W0105020105	Real-Time PCR Detection Kit for Hepatitis A Virus98/79	– 98/79	EUDAMED record Report an error
Hepatitis e virus - NA reagents	W0105020507	Real-time PCR Detection Kit for Hepatitis E Virus98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Iga, igd, igm, igg, ige	W0103080202	IgE (Immunoglobulin E) rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79	– 98/79	EUDAMED record Report an error
Integrated / modular chemistry / immunochemistry instruments - other	W02010399	Real-Time Quantitative PCR System X-poche16	A IVDR	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Rapid Test Cassette (Rare earth nano fluorescence immunochromatography)98/79	– 98/79	EUDAMED record Report an error
Microbiology devices - other	W05030399	Bacterial DNA Extraction Kit	A IVDR	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	Real-time PCR Detection Kit for Monkeypox Virus2 refs98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox virus (MPXV) Antigen Rapid Test Cassette9 refs98/79	– 98/79	EUDAMED record Report an error
Mycobacteria reagents - other	W0105010799	"Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Test Cassette (Rare earth nanorare earth nano fluorescence immunochromatography)"98/79	– 98/79	EUDAMED record Report an error
Mycobacterial antibody assays	W0105010702	Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR)98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Mycoplasma Pneumoniae IgM/IgG Antibody Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Mycoplasma pneumoniae detection by NA reagents	W010501080301	Real-time PCR Detection Kit for Mycoplasma Pneumoniae98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	PCR-based HPV Test and 1618 Genotyping Test Kit (Fluorometric PCR)98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Real-time PCR Detection Kit for Respiratory Syncytial Virus98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Salmonella typhi IgM/IgG Antibody Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	Real-time PCR Detection Kit for Salmonella98/79	– 98/79	EUDAMED record Report an error
Samples collection devices - other	W05019099	Sampling Collector3 refs	A IVDR	EUDAMED record Report an error
Shigella - NA reagents	W0105011614	Real-time PCR Detection Kit for Shigella Strains98/79	– 98/79	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	PCR-based Group B Streptococcus Test Kit (Fluorometric PCR)98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody igg	W0105010303	Treponema Pallidum Antibody Rapid Test Cassette(Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Ureaplasma detection by NA reagents	W010501080303	PCR-based Ureaplasma Urealyticum Test Kit (Fluorometric PCR)98/79	– 98/79	EUDAMED record Report an error
Varicella zoster - NA reagents	W0105040904	Real-time PCR Detection Kit for Varicella-Zoster98/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	Real-time PCR Detection Kit for Zika98/79	– 98/79	EUDAMED record Report an error

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