Manufacturer

Poly Diagnostics

Luxembourg

First countries of placing on the market declared in EUDAMED : Luxembourg

32 categories, 71 models including 71 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Gastrointestinal infections - multiplex NA reagents	W0105070504	Poly Diagnostics Blastocystis hominis, RNase P Real-Time PCR kit3 refs Poly Diagnostics Cryptosporidium spp., E. histolytica, G. lamblia, RNase P Real-Time PCR kit3 refs Poly Diagnostics Cryptosporidium spp., RNase P Real-Time PCR kit3 refs Poly Diagnostics D. fragilis, B. hominis, C. cayetanensis, RNase P Real-Time PCR kit3 refs Poly Diagnostics Dientamoeba fragilis, RNase P Real-Time PCR kit3 refs 9 others Poly Diagnostics Entamoeba histolytica, RNase P Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Bacterial Panel III Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Panel I Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Parasite Panel IV Real-Time PCR kit3 refs Poly Diagnostics Gastrointestinal Disease Viral Panel II Real-Time PCR kit3 refs Poly Diagnostics Giardia lamblia, RNase P Real-Time PCR kit3 refs Poly Diagnostics Norovirus GI, Norovirus GII+GIV, Astrovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Sapovirus GI, II, IV, V, Adenovirus, Rotavirus A, RNase P Real-Time PCR kit3 refs Poly Diagnostics Vibrio cholerae, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Poly Diagnostics Influenza A, Influenza B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P, HRSV a/b Real-Time PCR kit3 refs Poly Diagnostics K. pneumoniae, M. catarrhalis, P. aeruginosa, RNase P Real-Time PCR kit3 refs Poly Diagnostics Respiratory Infection Viral Panel III Real-Time PCR kit3 refs 3 others Poly Diagnostics Respiratory Infection Viral Panel V Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, Bocavirus, HMPV A/B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, HRSV a/b, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Poly Diagnostics Influenza A, Influenza B, Influenza C, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza typing II Real-Time PCR kit3 refs Poly Diagnostics Influenza typing Real-Time PCR kit3 refs 2 others Poly Diagnostics Parainfluenza viruses 1, 2, 3, 4 Real-Time PCR kit3 refs Poly Diagnostics Parainfluenza viruses 1, 2, 3/4, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
E. coli detection by NA reagents	W0105011503	Poly Diagnostics E. coli Pathotyping Panel I Real-Time PCR kit3 refs Poly Diagnostics E. coli Pathotyping Panel II Real-Time PCR kit3 refs Poly Diagnostics E. coli Pathotyping Panel III Real-Time PCR kit3 refs Poly Diagnostics E.coli, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	Poly Diagnostics C. glabrata, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. krusei, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. parapsilosis, RNase P Real-Time PCR kit3 refs Poly Diagnostics C. tropicalis, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Mycology NA reagents - other	W0105060499	Poly Diagnostics Dermatophytes Panel I Real-Time PCR kit3 refs Poly Diagnostics Fusarium spp., RNase P Real-Time PCR kit3 refs Poly Diagnostics Pan-Dermatophyte, RNase P Real-Time PCR kit3 refs Poly Diagnostics Trichophyton rubrum, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	Poly Diagnostics Coronaviruses 229E, OC43, NL63, HKU1, RNase P Real-Time PCR kit3 refs Poly Diagnostics Coronaviruses 229E/HKU1, OC43, NL63, RNase P Real-Time PCR kit3 refs Poly Diagnostics SARS-CoV-2, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents	W0105070502	Poly Diagnostics Atopobium vaginae, Lactobacillus crispatus sensu Lato, Mobiluncus mulieris, RNase P Real-Time PCR kit3 refs Poly Diagnostics Bacteroides fragilis, Megasphaera type I, BVAB2, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Parechovirus - NA reagents	W0105040521	Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Parechovirus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Poly Diagnostics Adenovirus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Astrovirus - NA reagents	W0105040530	Poly Diagnostics Astrovirus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	Poly Diagnostics G. vaginalis, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Bocavirus - NA reagents	W0105040518	Poly Diagnostics Bocavirus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Poly Diagnostics B. parapertussis, B. pertussis, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Campylobacter detection by NA reagents	W0105011402	Poly Diagnostics Campylobacter coli/jejuni, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Candida albicans - NA reagents	W0105060402	Poly Diagnostics C. albicans, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex assays	W0105070203	Poly Diagnostics C. parapsilosis, C. tropicalis, C. krusei, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	Poly Diagnostics Helicobacter pylori, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Human metapneumovirus - NA reagents	W0105040517	Poly Diagnostics HMPV A/B, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	Poly Diagnostics Enterovirus, Mumps, Parechovirus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Mumps / parotitis - NA reagents	W0105040804	Poly Diagnostics Mumps virus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Poly Diagnostics Norovirus GI, Norovirus GII+GIV, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Pseudomonas detection by NA reagents	W0105010902	Poly Diagnostics Pseudomonas aeruginosa, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Poly Diagnostics HRSV a/b, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Rhinovirus - NA reagents	W0105040520	Poly Diagnostics Rhinovirus/Enterovirus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	Poly Diagnostics Rotavirus A, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	Poly Diagnostics Salmonella spp., RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Shigella - NA reagents	W0105011614	Poly Diagnostics Shigella/EIEC, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	Poly Diagnostics Staphylococcus aureus, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Poly Diagnostics Streptococcus pyogenes, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Tetanus (clostridium t.) - NA reagents	W0105011609	Poly Diagnostics C. difficile tcdA, tcdB Toxins Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error
Yersinia - NA reagents	W0105011606	Poly Diagnostics Yersinia enterocolitica, RNase P Real-Time PCR kit3 refs	B IVDR	EUDAMED record Report an error

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