Manufacturer

Remel Europe

United Kingdom (ex Northern Ireland)Legal entities : Remel Europe Ltd

Markets : Netherlands · United States

Approvals : EU – class A, C · United States (FDA) – 510(k) : 164 · class I, II · latest in 2017 · see on the FDA website

EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)

Website

11 categories, 25 models including 25 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
Streptococcal direct antigen detection	W0105011101	PATHODX STREP A GROUPING LATEX3 refs PATHODX STREP GROUPING KIT PATHODX STREP GROUPING UNIVERSAL KIT2 refs STREPTEX2 refs STREPTEX LATEX A3 refs 3 others STREPTEX RAPID Wellcogen S pneumoniae98/79 Wellcogen Strep B98/79	C IVDR, 98/79	EUDAMED record Report an error
Streptococcal reagents - other	W0105011199	PATHODX DISPOSABLE SLIDES PATHODX EXTRACTION REAGENT 13 refs PATHODX POSITIVE CONTROL STREPTEX ACID EXTRACTION KIT STREPTEX DISPOSABLE REACTION CARDS 2 others STREPTEX EXTRACTION ENZYME STREPTEX POLYVALENT POSITIVE CONTROL	C IVDR	EUDAMED record Report an error
Neisseria meningitidis	W0105011711	Wellcogen N. meningitdis B/E.coli K198/79 Wellcogen N. meningitidis ACY W13598/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Wellcogen Bacterial Antigen Kit98/79	– 98/79	EUDAMED record Report an error
Devices for samples analyses - other accessories	W05039080	WELLCOLEX DISPOSABLE CARDS	A IVDR	EUDAMED record Report an error
E. coli reagents - other	W0105011599	ProSpecT Microplate Assay Wash Buffer98/79	– 98/79	EUDAMED record Report an error
E. coli toxin	W0105011502	ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay98/79	– 98/79	EUDAMED record Report an error
Haemophilus influenzae	W0105011710	Wellcogen H influenzae b98/79	– 98/79	EUDAMED record Report an error
Hsv antigen	W0105040301	PATHODX HERPES TYPING KIT	C IVDR	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	WELLCOGEN EDTA SOLUTION	A IVDR	EUDAMED record Report an error
Other virology controls - inf.imm.	W0105080804	PATHODX HERPES TYPING CONTROL SLIDES	C IVDR	EUDAMED record Report an error

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