Manufacturer

Tellgencorp

ChinaLegal entities : Tellgen Corporation

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

EU representative : Medunion S.L. (Spain)

19 categories, 35 models including 35 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
Other interleukins (except for il-6)	W01030606	Interleukin-1 β Assay Kit（CLIA）12 refs98/79 Interleukin-10 Assay Kit（CLIA）12 refs98/79 Interleukin-12p70 Assay Kit（CLIA）12 refs98/79 Interleukin-17A Assay Kit（CLIA）12 refs98/79 Interleukin-2 Assay Kit（CLIA）12 refs98/79 3 others Interleukin-4 Assay Kit（CLIA）12 refs98/79 Interleukin-5 Assay Kit（CLIA）12 refs98/79 Interleukin-8 Assay Kit（CLIA）12 refs98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	MTB/RIF Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 MTB/XDR Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis Complex Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis Complex, Mycobacterium avium Complex and Mycobacterium abscessus Complex Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Mycobacterium tuberculosis, Haemophilus influenzae and Streptococcus pneumoniae Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	HPV 2+1298/79 HPV 5+998/79 HPV15 Genotyping Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Human Papillomavirus Nucleic Acid Detection and 16/18 Typing Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	SARS-CoV-2 /Influenza A/Influenza B/RSV Nucleic Acid Detection Kit98/79 SARS-CoV-2 /Influenza A/Influenza B/RSV/ADV/MP/MPV Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Dengue Virus 1-4/Zika Virus/Chikungunya Virus Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Dengue Virus/Zika Virus/ Chikungunya Virus Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	EUDAMED record Report an error
Aspergillus	W0105060301	Aspergillus Galactomannan (GM) Assay Kit (CLIA)（)18 refs98/79	– 98/79	EUDAMED record Report an error
Beta-d-glucan (pan-fungal markers)	W0105060304	Fungus (1-3)-β-D-glucan Assay Kit (CLIA)12 refs98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer（CLIA)8 refs98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Dengue Virus Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	EVU/CoxA16 and EV71 Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	FDP (CLIA)12 refs98/79	– 98/79	EUDAMED record Report an error
Fibrinolysis tests - other	W0103020599	t-PAIC (CLIA)12 refs98/79	– 98/79	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	TellgenplexTM HPV27 genotyping Assay98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 (CLIA)8 refs98/79	– 98/79	EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex	W0103020305	PIC (CLIA)12 refs98/79	– 98/79	EUDAMED record Report an error
Samples transport, containers - other	W05020199	48 Bottles/Kit	A IVDR	EUDAMED record Report an error
SS-thromboglobulin	W0103020405	TM-7 (CLIA)12 refs98/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	TAT(CLIA)12 refs98/79	– 98/79	EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...)	W01030603	Tumour Necrosis Factor-α Assay Kit（CLIA）11 refs98/79	– 98/79	EUDAMED record Report an error

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