Manufacturer

Diagreat

ChinaLegal entities : Beijing Diagreat Biotechnologies Co., Ltd.

Markets : Italy

Approvals : EU – class A, B, C

EU representative : MedNet EC-REP GmbH (Germany)

Website info@diagreat.com

24 categories, 42 models including 42 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
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Acid Cleaning Solution 100mL×1 Alkaline Cleaning Solution 100mL×1 Chemiluminescent Substrate 100mL×12 refs Chemiluminescent Wash Solution 0 .5L×12 refs Whole Blood Sample Extraction Reagent SF004	A IVDR	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	25 tests/box Malaria P.f Antigen Rapid Test Kit 25 tests/box Malaria P.f/P.v Antigen Combo Rapid Test Kit 25 tests/box Malaria P.f/Pan Antigen Combo Rapid Test Kit 25 tests/box PV and HB Combo Rapid Test Kit 25 tests/box	C IVDR	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue IgG/IgM Rapid Test Kit 25 tests/box Dengue NS1 Antigen & IgG/IgM Combo Rapid Test Kit 25 tests/box Dengue NS1 Antigen Rapid Test Kit 25 tests/box	B, C IVDR	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	2019-nCoV and Influenza A/B Combo Antigen Test Kit 25 tests/box 2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit 25 tests/box Influenza A/B Antigen Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests/box	B IVDR	EUDAMED record Report an error
Other interleukins (except for il-6)	W01030606	Interleukin-10 CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Interleukin-1β CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Interleukin-8 CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box	B IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box D-Dimer Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests	B IVDR	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H. pylori Ag Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests/box H. pylori Ag Rapid Test Kit 25 tests/box	B IVDR	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin-6 CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box Interleukin-6 Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests	B IVDR	EUDAMED record Report an error
Streptococcal direct antigen detection	W0105011101	Group A Streptococcus Antigen Rapid Test Kit 25 tests/box Group B Streptococcus Antigen Rapid Test Kit 25 tests/box	C IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Automatic Chemiluminescence Immunoassay Analyzer DF100/DF100i	A IVDR	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Carbapenem Resistant Enterobacteriaceae Rapid Test Kit 25 tests/box	B IVDR	EUDAMED record Report an error
Coronavirus ag	W0105041101	2019-nCoV Antigen Rapid Test Kit 25 tests/box	B IVDR	EUDAMED record Report an error
Coronavirus antibodies - total	W0105041102	2019-nCoV IgG/gM Antibody Rapid Test Kit 25 tests/box	B IVDR	EUDAMED record Report an error
Coronavirus igg	W0105041103	2019-nCoV IgG Antibody Determination Kit 25 tests/box	B IVDR	EUDAMED record Report an error
Coronavirus igm	W0105041104	2019-nCoV IgM Antibody Determination Kit 25 tests/box	B IVDR	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H.pylori Antibody Rapid Test Kit 25 tests/box	C IVDR	EUDAMED record Report an error
Influenza & para influenza	W0105040604	Influenza A/B Antigen Rapid Test Kit 25 tests/box	B IVDR	EUDAMED record Report an error
Interleukins receptors (il-2r,il6r ...)	W01030607	Interleukin-2 Receptor CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box	B IVDR	EUDAMED record Report an error
Mycobacterial antibody assays	W0105010702	TB IgG/IgM Rapid Test Kit 25 tests/box	C IVDR	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Mycoplasma Pneumoniae IgM Rapid Test Kit 25 tests/box	B IVDR	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Typhoid IgG/IgM Rapid Test Kit 25 tests/box	C IVDR	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Syphilis Antibody Rapid Test Kit 25 tests/box	C IVDR	EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...)	W01030603	α Tumor Necrosis Factor CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box	B IVDR	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	Monkeypox Virus Ag Test Kit 25 tests/box	C IVDR	EUDAMED record Report an error

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