Fabricant

AusDiagnostics

AustralieEntités : AusDiagnostics Pty Ltd

Premiers pays de mise sur le marché déclarés dans EUDAMED : Allemagne, Italie, Malte

Mandataire UE : Advena Limited (Malte)

17 catégories, 137 modèles dont 137 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Respiratory tract infections - multiplex NA reagents	W0105070503	Respiratory Pathogens 12-well98/79 Respiratory Pathogens 12-well 80618P98/79 RIDA®Plex Atypical Pneumonia 8 well Step 198/79 RIDA®Plex Atypical Pneumonia 8 well Step 298/79 RIDA®Plex Pneumonia 16 well Step 198/79 35 autres RIDA®Plex Pneumonia 16 well Step 298/79 RIDA®Plex Respiratory Pathogens 12 well Step 198/79 RIDA®Plex Respiratory Pathogens 12 well Step 298/79 RIDA®Plex Respiratory Pathogens 16 well Step 198/79 RIDA®Plex Respiratory Pathogens 16 well Step 298/79 RIDA®Plex Respiratory Pathogens 24 well Step 198/79 RIDA®Plex Respiratory Pathogens 24 well Step 298/79 RIDA®Plex Respiratory Pathogens B 16 well Step 198/79 RIDA®Plex Respiratory Pathogens B 16 well Step 298/79 RIDA®Plex Respiratory Pathogens C 16 well Step 198/79 RIDA®Plex Respiratory Pathogens C 16 well Step 298/79 RIDA®Plex Respiratory Viruses 16 well Step 198/79 RIDA®Plex Respiratory Viruses 16 well Step 298/79 RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 198/79 RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 298/79 RIDA®Plex Upper Respiratory Pathogens 16 well Step 198/79 RIDA®Plex Upper Respiratory Pathogens 16 well Step 298/79 Step 1 tubes for Atypical Pneumonia (8-well)98/79 Step 1 tubes for Pneumonia (16-well)98/79 Step 1 tubes for Respiratory Pathogens 16-well98/79 Step 1 tubes for Respiratory Pathogens 24-well98/79 Step 1 tubes for Respiratory Pathogens B 16-well98/79 Step 1 tubes for Respiratory Pathogens C 16-well98/79 Step 1 tubes for Respiratory Viruses (16-well)98/79 Step 1 tubes for SARS-CoV-2, Influenza and RSV 8-well98/79 Step 1 tubes for Upper Respiratory Pathogens 16-well98/79 Step 2 Plates for Atypical Pneumonia 8-well98/79 Step 2 Plates for Pneumonia (16-well)98/79 Step 2 Plates for Respiratory Pathogens 16-well98/79 Step 2 Plates for Respiratory Pathogens 24-well98/79 Step 2 Plates for Respiratory Pathogens B 16-well98/79 Step 2 Plates for Respiratory Pathogens C 16-well98/79 Step 2 Plates for Respiratory Viruses (16-well)98/79 Step 2 Plates for SARS-CoV-2, Influenza and RSV 8-well98/79 Step 2 Plates for Upper Respiratory Pathogens 16-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gastrointestinal infections - multiplex NA reagents	W0105070504	RIDA®Plex Enteric Viruses 8 well Step 198/79 RIDA®Plex Enteric Viruses 8 well Step 298/79 RIDA®Plex Faecal Bacteria and Parasites 12 well Step 198/79 RIDA®Plex Faecal Bacteria and Parasites 12 well Step 298/79 RIDA®Plex Faecal Pathogens A 16 well Step 198/79 15 autres RIDA®Plex Faecal Pathogens A 16 well Step 298/79 RIDA®Plex Faecal Pathogens B 16 well Step 198/79 RIDA®Plex Faecal Pathogens B 16 well Step 298/79 RIDA®Plex Faecal Pathogens M 16 well Step 198/79 RIDA®Plex Faecal Pathogens M 16 well Step 298/79 Step 1 tubes for Enteric Viruses 8-well98/79 Step 1 tubes for Faecal Bacteria and Parasites 12-well98/79 Step 1 tubes for Faecal Pathogens A 16-well98/79 Step 1 tubes for Faecal Pathogens B 16-well98/79 Step 1 tubes for Faecal Pathogens M 16-well98/79 Step 2 Plates for Enteric Viruses 8-well98/79 Step 2 Plates for Faecal Bacteria and Parasites 12-well98/79 Step 2 Plates for Faecal Pathogens A 16-well98/79 Step 2 Plates for Faecal Pathogens B 16-well98/79 Step 2 Plates for Faecal Pathogens M 16-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - multiplex assays - other	W0105070399	RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Step 198/79 RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Step 298/79 RIDA®Plex Viral 12 well Step 198/79 RIDA®Plex Viral 12 well Step 298/79 RIDA®Plex Viral 8 well Step 198/79 12 autres RIDA®Plex Viral 8 well Step 298/79 RIDA®Plex Viral and Syphilis 12 well Step 198/79 RIDA®Plex Viral and Syphilis 12 well Step 298/79 Step 1 tubes for Herpes, Enterovirus and Adenovirus 8-well98/79 Step 1 tubes for Viral 8-well98/79 Step 1 tubes for Viral CSF (8-well)98/79 Step 1 tubes for Viral Panel 12-well98/79 Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well98/79 Step 2 Plates for Viral 8-well98/79 Step 2 Plates for Viral CSF (8-well)98/79 Step 2 Plates for Viral Panel 12-well98/79 Viral and Syphilis 12-well2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiconstituent controls - inf.imm.	W0105080807	RIDA®Plex Positive Control Bacteria and Resistances98/79 RIDA®Plex Positive Control CSF98/79 RIDA®Plex Positive Control Faecal Pathogens98/79 RIDA®Plex Positive Control Fungal Panels98/79 RIDA®Plex Positive Control Pneumonia98/79 10 autres RIDA®Plex Positive Control Respiratory Pathogens98/79 RIDA®Plex Positive Control STIs and Herpes98/79 Synthetic Positive Controls for Atypical Pneumonia98/79 Synthetic Positive Controls for Bacteria and Bacterial Resistance98/79 Synthetic Positive Controls for CSF98/79 Synthetic Positive Controls for Faecal Panels98/79 Synthetic Positive Controls for Fungal Panels98/79 Synthetic Positive Controls for HPV98/79 Synthetic Positive Controls for Respiratory Pathogens98/79 Synthetic Positive Controls for STIs and Herpes98/79	– 98/79	Fiche EUDAMED Signaler une erreur
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	RIDA®Plex STI 16 well Step 198/79 RIDA®Plex STI 16 well Step 298/79 RIDA®Plex Urinogenital 8 well Step 198/79 RIDA®Plex Urinogenital 8 well Step 298/79 RIDA®Plex Urinogenital and Resistance 12 well Step 12 réf.98/79 8 autres RIDA®Plex Urinogenital and Resistance 12 well Step 22 réf.98/79 Step 1 tubes for STI (16-well)98/79 Step 1 tubes for Urinogenital (8-well)98/79 Step 1 tubes for Urinogenital and Resistance 12 well2 réf.98/79 Step 2 Plates for STI (16-well)98/79 Step 2 Plates for Urinogenital (8-well)98/79 Step 2 Plates for Urinogenital and Resistance 12 well Multiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagent98/79 Step 2 Plates for Urinogenital and Resistance 12-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gram+ - gram- - fungi - multiplex assays	W0105070203	RIDA®Plex Vaginitis and Vaginosis 12 well Step 198/79 RIDA®Plex Vaginitis and Vaginosis 12 well Step 298/79 RIDA®Plex Vaginitis and Vaginosis 8 well Step 198/79 RIDA®Plex Vaginitis and Vaginosis 8 well Step 298/79 Step 1 tubes for Vaginitis and vaginosis 12-well98/79 3 autres Step 1 tubes for Vaginitis and vaginosis 8-well98/79 Step 2 Plates for Vaginitis and vaginosis 12-well98/79 Step 2 Plates for Vaginitis and vaginosis 8-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	RIDA®Plex CSF 16 well Step 198/79 RIDA®Plex CSF 16 well Step 298/79 Step 1 tubes for CSF 16-well98/79 Step 2 Plates for CSF 16-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple parasites panels	W01050704	RIDA®Plex Parasites 8 well Step 198/79 RIDA®Plex Parasites 8 well Step 298/79 Step 1 tubes for Parasites 8-well98/79 Step 2 Plates for Parasites 8-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other multiple infectious - multiplex NA reagents	W0105070502	RIDA®Plex Staphylococcus and VRE 8 well Step 198/79 RIDA®Plex Staphylococcus and VRE 8 well Step 298/79 Step 1 tubes for Staphylococcus + VRE 8-well98/79 Step 2 Plates for Staphylococcus + VRE 8-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Staphylococcal detection by NA reagents	W0105011203	RIDA®Plex Staphylococcus Typing 8 well Step 198/79 RIDA®Plex Staphylococcus Typing 8 well Step 298/79 Step 1 tubes for Staphylococcus typing 8-well98/79 Step 2 Plates for Staphylococcus typing 8-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Partial genotyping high-risk HPV - NA reagents	W0105041003	Step 1 tubes for High Risk HPV Genotyping 8-well98/79 Step 2 Plates for High Risk HPV Genotyping 8-well98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Buffers (unassignable ), supplem. reagents, etc	W0105900201	RIDA®Prep Tissue Digestion Kit	A IVDR	Fiche EUDAMED Signaler une erreur
DNA genomic preparation devices	W02050106	MT-Prep 24 System3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
DNA thermal cyclers	W02039006	HighPlex Ascend System3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	Demi DNA Reagent Cassette3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	MT-Prep Blood DNA Extraction kit 1200 (48 samples)3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Supplemental NA reagents	W0105900103	Extraction Control	A IVDR	Fiche EUDAMED Signaler une erreur

Un modèle enregistré dans EUDAMED n'est pas forcément commercialisé dans votre pays. Vérifiez la disponibilité et le marquage CE auprès du fabricant.

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