Manufacturer

Molbio Diagnostics

IndiaLegal entities : Molbio Diagnostics Limited

Markets : Austria · Belgium · Germany · Italy

Approvals : EU – class A, C

EU representative : QbD RepS BV (Belgium)

Website customersupport@molbiodiagnostics.com

13 categories, 51 models including 51 on the market, 1 country

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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
Coronavirus - NA reagents	W0105041106	Truemix COVID-19 70143000898/79 Truemix COVID-19 70143002498/79 Truemix COVID-19 70143004898/79 Truemix COVID-19 70143009698/79 Truenat COVID-19 60143000598/79 3 others Truenat COVID-19 60143002098/79 Truenat COVID-19 60143002598/79 Truenat COVID-19 60143005098/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Truenat MTB Plus 60113000598/79 Truenat MTB Plus 60113002098/79 Truenat MTB Plus 60113002598/79 Truenat MTB Plus 60113005098/79 Truenat MTB-RIF Dx 60121000598/79 3 others Truenat MTB-RIF Dx 60121002098/79 Truenat MTB-RIF Dx 60121002598/79 Truenat MTB-RIF Dx 60121005098/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	STABILYSE Prep Free 90101PF05, 90101PF20, 90101PF25, 90101PF503 refs Trueprep AUTO MTB Sample Pre-treatment Pack 60204AS05, 60204AS20, 60204AS25, 60204AS503 refs Trueprep AUTO Universal Cartridge Based Sample Prep Kit 60203AR25, 60203AR502 refs Trueprep AUTO Universal Sample Pre-treatment Pack 60205AB05, 60205AB20, 60205AB25, 60205AB503 refs Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit 60207AR50	A IVDR	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	Truenat GBS 60124000598/79 Truenat GBS 60124002098/79 Truenat GBS 60124002598/79 Truenat GBS 60124005098/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Truenat Influenza A/B 60120000598/79 Truenat Influenza A/B 60120002098/79 Truenat Influenza A/B 60120002598/79 Truenat Influenza A/B 60120005098/79	– 98/79	EUDAMED record Report an error
Leptospira - NA reagents	W0105011604	Truenat LTS 60140000598/79 Truenat LTS 60140002098/79 Truenat LTS 60140002598/79 Truenat LTS 60140005098/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	Truenat Dengue/Chikungunya 60104000598/79 Truenat Dengue/Chikungunya 60104002098/79 Truenat Dengue/Chikungunya 60104002598/79 Truenat Dengue/Chikungunya 60104005098/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Truenat Malaria Pv/Pf 60101002098/79 Truenat Malaria Pv/Pf 60101005098/79 Truenat® Malaria Pv/Pf 60101000598/79 Truenat® Malaria Pv/Pf 60101002598/79	– 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Truenat H1N1 60107000598/79 Truenat H1N1 60107002098/79 Truenat H1N1 60107002598/79 Truenat H1N1 60107005098/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments - rapid and point of care tests - other	W02050399	Truelab® Duo 603022001 Truelab® Quattro 603023001 Truelab® Uno Dx 603021001	A IVDR	EUDAMED record Report an error
Samples transport, containers - other	W05020199	Trueprep AUTO Transport Medium for Swab Specimen Pack 60206TS05, 60206TS20,60206TS25, 60206TS503 refs	A IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Truenat CT/NG 601160005, 601160020, 601160025, 601160050, 601160100, 6011602003 refs	C IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Trueprep® AUTO v2 603042001	A IVDR	EUDAMED record Report an error

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