Manufacturer

Suzhou TianLong Biotechnology

ChinaLegal entities : Suzhou TianLong Biotechnology Co., Ltd.

Markets : France · Germany · Italy · United States

Approvals : United States (FDA) – · class I, II

EU representative : Lotus NL B.V. (Netherlands)

27 categories, 49 models including 49 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 - NA reagents - other	W0105040599	Coxsackie A6/A10 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Dengue Virus/ZiKa Virus/Chikungunya Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Diarrhea Virus (5 Viruses) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Enterovirus 71/Coxsackie A16/ Enterovirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 Influenza A/Influenza B/Human Adenovirus/2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 4 others Influenza A/Influenza B/SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Sapovirus/Adenovirus/Astrovirus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Yellow Fever Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Human Influenza Virus A/B / Respiratory Syncytial Virus/SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory 12 Types Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Respiratory 15 Types Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method-0.2mL Pre-filled)98/79 Respiratory Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory Virus Nucleic Acid Detection Kit (Fluorescence PCR Method; Pre-filled)98/79 2 others Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)98/79 Respiratory 7 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Human Influenza Virus A/B & Respiratory Syncytial Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B (Yamagata&Victoria) and A (H1&H3) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B Genotyping (Yamagata&Victoria) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Influenza A/B Virus RNA Detection Kit (Fluorescence PCR Method)98/79 Influenza A/Influenza B/Respiratory Syncytial Virus (RSV) Nucleic Acid Detection Kit (Fluorescence PCR Method-0.1mL Pre-filled)98/79	– 98/79	EUDAMED record Report an error
Hantavirus / bunyavirus - NA reagents	W0105040514	Andes virus (ANDV) Nucleic Acid Detection Kit (Fluorescence PCR Method)2 refs98/79 Hantaan Virus/Seoul Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Respiratory Syncytial Virus Genotype A/B Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory Syncytial Virus Universal RNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	Rotavirus Genotype A/B/C Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Rotavirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	Salmonella DNA Detection Kit (Fluorescence PCR Method)98/79 Salmonella Enterica/Shigella Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Human Adenovirus (Ad) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Astrovirus - NA reagents	W0105040530	Astrovirus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Avian influenza - NA reagents	W0105040515	Avian Influenza Virus H7 Universal/HPAI-H7/N9 Subtype RNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	Vibrio Cholerae O139/O1 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Bacillus Pertussis Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Dengue Virus Genotyping (I/II/III/IV) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
E. coli detection by NA reagents	W0105011503	Escherichia Coli DNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Ebola (filovirus) - NA reagents	W0105040528	Ebola Virus (Zaire) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	EB Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	Enterovirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	Neisseria Gonorrhoeae (NG) Nucleic Acid Detection Kit (Fluorescence PCR Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Human metapneumovirus - NA reagents	W0105040517	Human Metapneumovirus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Legionella detection by NA reagents	W0105010503	Legionella Pneumophila Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Listeria detection by NA reagents	W0105011305	Listeria Monocytogenes DNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Norovirus (NoV) Genotype GI/GII Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	Staphylococcus Aureus DNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	Group B Streptococcus (GBS) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	ZiKa Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error

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