Manufacturer

Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi

TürkiyeLegal entities : ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI

Markets : Türkiye

Approvals : EU – class C

39 categories, 121 models including 121 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
Mycobacterial detection by NA reagents	W0105010703	MTB Detection and Monitoring Kit (24)3 refs98/79 MTB Detection and Monitoring Kit (48)3 refs98/79 MTB Detection and Monitoring Kit (96)3 refs98/79 MTB/MDR Detection and Monitoring Kit (24)3 refs98/79 MTB/MDR Detection and Monitoring Kit (48)3 refs98/79 5 others MTB/MDR Detection and Monitoring Kit (96)3 refs98/79 MTB/NTM Detection and Monitoring Kit (24)3 refs98/79 MTB/NTM Detection and Monitoring Kit (48)3 refs98/79 MTB/NTM Detection and Monitoring Kit (96)3 refs98/79 TB-XDR Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	Bacterial Meningitis Detection and Monitoring Kit (24)3 refs98/79 Bacterial Meningitis Detection and Monitoring Kit (48)3 refs98/79 Bacterial Meningitis Detection and Monitoring Kit (96)3 refs98/79 Meningitis Detection and Monitoring Kit (24)3 refs98/79 Meningitis Detection and Monitoring Kit (48)3 refs98/79 4 others Meningitis Detection and Monitoring Kit (96)3 refs98/79 Viral Meningitis Detection and Monitoring Kit (24)3 refs98/79 Viral Meningitis Detection and Monitoring Kit (48)3 refs98/79 Viral Meningitis Detection and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Covid Flu RSV Detection and Monitoring Kit (24)3 refs98/79 Covid Flu RSV Detection and Monitoring Kit (48)3 refs98/79 Covid Flu RSV Detection and Monitoring Kit (96)3 refs98/79 Respiratory Fast Screening and Monitoring Kit (24)3 refs98/79 Respiratory Fast Screening and Monitoring Kit (48)3 refs98/79 4 others Respiratory Fast Screening and Monitoring Kit (96)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (24)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (48)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	Eye Infection Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (48)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (96)3 refs98/79 Monkeypox Virus Detection and Monitoring Kit (24)3 refs98/79 3 others Sapovirus Detection and Monitoring Kit (24)3 refs98/79 Sapovirus Detection and Monitoring Kit (48)3 refs98/79 Urinary Tract Infection Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Aspergillus - NA reagents	W0105060401	Aspergillus Identification and Monitoring Kit (24)3 refs98/79 Aspergillus Identification and Monitoring Kit (48)3 refs98/79 Aspergillus Identification and Monitoring Kit (96)3 refs98/79 Aspergillus/Fusarium/Trichosporon Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Adenovirus Quantification Kit (24)3 refs98/79 Adenovirus Quantification Kit (48)3 refs98/79 Adenovirus Quantification Kit (96)3 refs	C IVDR, 98/79	EUDAMED record Report an error
Bk virus	W0105040622	BKV Quantification Kit (24)3 refs98/79 BKV Quantification Kit (48)3 refs98/79 BKV Quantification Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Candida auris - NA reagents	W0105060404	Candida Auris Detection and Monitoring Kit (24)3 refs98/79 Candida Auris Detection and Monitoring Kit (48)3 refs98/79 Candida Auris Detection and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	SARS-CoV-2 Detection and Monitoring Kit (24)3 refs98/79 SARS-CoV-2 Detection and Monitoring Kit (48)3 refs98/79 SARS-CoV-2 Detection and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	EBV Quantification Kit (24)3 refs98/79 EBV Quantification Kit (48)3 refs98/79 EBV Quantification Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	HPV Genotyping and Monitoring Plus Kit (24)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (48)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	Helicobacter pylori Detection and Monitoring Kit (24)2 refs98/79 Helicobacter pylori Detection and Monitoring Kit (24) Helicobacter pylori Detection and Monitoring Kit (48)98/79 Helicobacter pylori Detection and Monitoring Kit (48)3 refs98/79	– 98/79	EUDAMED record Report an error
Hepatitis c virus (HCV) genotyping - NA reagents	W0105020309	HCV Genotyping Kit (24)3 refs98/79 HCV Genotyping Kit (48)3 refs98/79 HCV Genotyping Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Hhv-6,7,8 - NA reagents	W0105040524	HHV6 Quantification Kit (24)3 refs98/79 HHV6 Quantification Kit (48)3 refs98/79 HHV6 Quantification Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	HSV 1/2 Quantification Kit (24)3 refs98/79 HSV 1/2 Quantification Kit (48)3 refs98/79 HSV 1/2 Quantification Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza-A Virus Detection and Monitoring Kit (24)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (48)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Jc virus	W0105040623	JCV Quantification Kit (24)3 refs98/79 JCV Quantification Kit (48)3 refs98/79 JCV Quantification Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Multiple parasites panels	W01050704	Enteric Parasite Detection and Monitoring Kit (24)3 refs98/79 Enteric Parasite Detection and Monitoring Kit (48)3 refs98/79 Plasmodium Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	HPV LR Genotyping and Monitoring Kit (24)3 refs98/79 HPV LR Genotyping and Monitoring Kit (48)3 refs98/79 HPV LR Genotyping and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents	W0105070502	Joint Infection Detection and Monitoring Kit (24)3 refs98/79 Joint Infection Detection and Monitoring Kit (48)3 refs98/79 Joint Infection Detection and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	HPV Genotyping and Monitoring Kit (24)3 refs98/79 HPV Genotyping and Monitoring Kit (48)3 refs98/79 HPV Genotyping and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Parvovirus b 19 - NA reagents	W0105040509	Parvovirus B19 Quantification Kit (24)3 refs98/79 Parvovirus B19 Quantification Kit (48)3 refs98/79 Parvovirus B19 Quantification Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Screening high-risk HPV - NA reagents	W0105041002	HPV Screening and Monitoring Kit (24)3 refs98/79 HPV Screening and Monitoring Kit (48)3 refs98/79 HPV Screening and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	STDs Detection and MonitoringKit (24)3 refs98/79 STDs Detection and MonitoringKit (48)3 refs98/79 STDs Detection and MonitoringKit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Vzv - RT & POC	W0105099006	VZV Quantification Kit (24)3 refs98/79 VZV Quantification Kit (48)3 refs98/79 VZV Quantification Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	West Nile Virus Detection and Monitoring Kit (24)3 refs98/79 West Nile Virus Detection and Monitoring Kit (48)3 refs98/79 West Nile Virus Detection and Monitoring Kit (96)3 refs98/79	– 98/79	EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents	W0105070202	Bacterial Sepsis Detection and Monitoring Kit (24)3 refs98/79 Sepsis Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridioides difficile Detection and Monitoring Kit (24)3 refs98/79 Clostridioides difficile Detection and Monitoring Kit (48)3 refs98/79	– 98/79	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex assays	W0105070203	Enteric Bacterial Detection and Monitoring Kit (24)3 refs98/79 Enteric Bacterial Detection and Monitoring Kit (48)3 refs98/79	– 98/79	EUDAMED record Report an error
Measles - NA reagents	W0105040704	Measles VirusDetection and Monitoring Kit (24)2 refs98/79 Measles VirusDetection and Monitoring Kit (24) Measles Virus Detection and Monitoring Kit (24)98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	Enteric Viral Panel Detection and Monitoring Kit (24)3 refs98/79 Enteric Viral Panel Detection and Monitoring Kit (48)3 refs98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Bordetella Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Candida albicans - NA reagents	W0105060402	Candida Detection and Monitoring Kit (24)98/79	– 98/79	EUDAMED record Report an error
Legionella detection by NA reagents	W0105010503	Legionella pneumophila Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Mumps / parotitis - NA reagents	W0105040804	Mumps Virus Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Mycology NA reagents - other	W0105060499	Candida Detection and Monitoring Kit (24)2 refs98/79	– 98/79	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	Salmonella spp Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Streptococcus Pyogenes Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Tropical Fever Detection and Monitoring Kit (24)3 refs98/79	– 98/79	EUDAMED record Report an error

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