Manufacturer

AccuBioTech

ChinaLegal entities : AccuBioTech Co., Ltd.

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

EU representative : MDSS GmbH (Germany)

18 categories, 63 models including 63 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
Virology - RT & POC - other	W0105099099	Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab)98/79 Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab/Nasopharyngeal Swab)98/79 Accu-Tell® COVID-19 Antigen Cassette (Saliva)98/79 Accu-Tell® COVID-19 Antigen Cassette (Saliva/ Nasopharyngeal Swab)98/79 Accu-Tell® COVID-19 IgG/IgM Cassette (Whole Blood/ Serum/ Plasma)98/79 8 others Accu-Tell® Human Monkeypox virus Antibody Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Human Monkeypox virus Cassette (Lesion exudate swab)98/79 Accu-Tell® Rotavirus Cassette (Feces)98/79 Accu-Tell® Rotavirus/Adenovirus Combo Cassette(Feces)98/79 Accu-Tell® SARS-CoV-2 (Nasopharyngeal Swab)98/79 Accu-Tell® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma)98/79 Accu-Tell® SARS-CoV-2+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab)98/79 SARS-CoV-2 Neutralizing Antibody Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Accu-Tell® H. pylori Antigen Cassette (Feces)98/79 Accu-Tell® H. pylori IgG Cassette(Serum/Plasma)98/79 Accu-Tell® H. pylori IgG Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Cassette(Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Strip （Whole Blood/Serum/Plasma)98/79 1 other Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	Accu-Tell® HAV IgG Cassette (Serum/Plasma）98/79 Accu-Tell® HAV IgM Strip (Serum/Plasma)98/79 Accu-Tell® HAV IgM/IgG Cassette(Serum/Plasma)98/79 Accu-Tell® HAV IgM/IgG Strip(Serum/Plasma)98/79 Accu-Tell® HEV IgM Cassette(Serum/Plasma)98/79 1 other Accu-Tell®HAV IgM Cassette(Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Accu-Tell® TB Cassette (Serum/Plasma)98/79 Accu-Tell® TB Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® TB Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Typhoid Cassette (Serum/Plasma)98/79 Accu-Tell® Typhoid Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Accu-Tell® Dengue IgG/IgM Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Serum/Plasma)98/79 Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Dengue NS1 Antigen Cassette (Serum/Plasma)98/79 Accu-Tell® Dengue NS1 Antigen Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Accu-Tell® Malaria P.f. Cassette(Whole Blood)98/79 Accu-Tell® Malaria P.f./P.v. Cassette(Whole Blood)98/79 Accu-Tell®Malaria p.f./p.v./pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Strip(Whole Blood)98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Accu-Tell® Syphilis Cassette (Serum/Plasma)98/79 Accu-Tell® Syphilis Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Syphilis Strip (Serum/Plasma)98/79 Accu-Tell® Syphilis Strip (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Accu-Tell® Clostridium difficile GDH Cassette (Feces)98/79 Accu-Tell® Clostridium difficile GDH +Toxin A+ Toxin B Combo Cassette (Feces)98/79 Accu-Tell® Clostridium difficile Toxin A+ Toxin B Combo Cassette (Feces)98/79	– 98/79	EUDAMED record Report an error
Chagas	W0105050202	Accu-Tell® Chagas Cassette(Whole Blood/Serum/Plasma)98/79 Accu-Tell® Chagas Strip (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	Accu-Tell® D-Dimer Cassette (Whole Blood/Plasma/Serum)98/79 Accu-Tell® D-Dimer Strip (Whole Blood/Plasma/Serum)98/79	– 98/79	EUDAMED record Report an error
Entamoeba histolytica	W0105050201	Accu-Tell® Entamoeba histolytica Strip (Feces)98/79 Accu-Tell® Entamoeba Histolytica Cassette (Feces)98/79	– 98/79	EUDAMED record Report an error
Giardia lamblia	W0105050208	Accu-Tell® Giardia lamblia Cassette (Feces)98/79 Accu-Tell® Giardia lamblia Strip (Feces)98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Accu-Tell® Influenza A+B Cassette (Swab/Nasal Aspirate)98/79 Accu-Tell® Influenza A+B Strip (Swab/ Nasal Aspirate)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Accu-Tell® Strep A Cassette (Throat Swab)98/79 Accu-tell® Strep A Strip (Throat Swab)98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Accu-Tell® Chikungunya IgG/IgM Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Accu-Tell® Legionella Pneumophila Antigen Cassette (Urine)98/79	– 98/79	EUDAMED record Report an error
Norovirus	W0105040616	Accu-Tell® Norovirus Cassette (Feces)98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Accu-Tell® RSV Antigen Cassette (Swab)98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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