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REMEL EUROPE LIMITED

Last updated May 24, 2026

What REMEL EUROPE LIMITED makes

The company produces in vitro diagnostic (IVD) reagents, kits, and controls for detecting microbial antigens, including respiratory viruses like influenza and RSV, Escherichia coli (including O157:H7), multiple Rickettsia species, Chlamydia trachomatis, and meningitis-associated bacteria. Products include agglutination-based assays, microplate reagents, and control slides for laboratory testing, as well as agglutinating sera for bacterial identification. Some devices are designed for rapid or agglutination-based detection, while others support culture-based diagnostics.

The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with several listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, where its products are subject to FDA oversight for in vitro diagnostic devices. No specific regulatory approvals or certifications are implied beyond individual device authorisations where applicable.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: remel.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +4401322295600
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 232600853

Catalogue (39)

Device	Model / Reference	Registries	Class	Status
PathoDX RVP Control Slides	R62414	FDA UDI	Class I	Active
EDTA Solution	R30164501	FDA UDI	Class II	Active
ProSpecT Microplate Assay Wash Buffer	R2450002	FDA UDI	Class I	Active
ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay	R2474096	FDA UDI	Class I	Active
Wellcolex E.coli O157:H7	R30959601	FDA UDI	Class I	Active
Vibrio cholerae Inaba Agglutinating Sera	R30165101	FDA UDI	Class II	Active
Escherichia coli Polyvalent 3 Types O86(B7), O114:K90, O125(B15), O127(B8), O128	R30955001	FDA UDI	Class I	Active
Wellcogen S pneumoniae	R30859001	FDA UDI	Class I	Active
Disposable Cards RT04	R30368701	FDA UDI	Class II	Active
Proteus OX19 Agglutinating Serum	R30165801	FDA UDI	Class I	Active
PathoDX RSV Reagent	R62411	FDA UDI	Class I	Active
PathoDX Influenza A Reagent	R62405	FDA UDI	Class I	Active
PathoDX Influenza B Reagent	R62406	FDA UDI	Class I	Active
Salmonella H z Agglutinating Sera	R30162401	FDA UDI	Class II	Active
PathoDx Parainfluenza 3 Reagent	R62410	FDA UDI	Class I	Active
ProSpecT Microplate Assay Wash Buffer	R24500011	FDA UDI	Class I	Active
Proteus OX19 Stained Suspension	R30953701	FDA UDI	Class I	Unknown
PathoDx Chlamydia Culture Confirmation	R62210	FDA UDI	Class I	Active
PathoDx Parainfluenza 1 Reagent	R62408	FDA UDI	Class I	Active
PathoDX RSV Direct Specimen	R62370	FDA UDI	Class I	Active
Bordetella parapertussis Agglutinating Serum	R30165601	FDA UDI	Class I	Active
Sample Collection Tubes	R30853001	FDA UDI	Class I	Unknown
Wellcogen Strep B	R30858701	FDA UDI	Class I	Active
Wellcolex E.coli O157	R30959501	FDA UDI	Class I	Active
PathoDX Respiratory Viral Panel	R62400	FDA UDI	Class I	Active
PathoDx Parainfluenza 2 Reagent	R62409	FDA UDI	Class I	Active
PathoDX Adenovirus Reagent	R62407	FDA UDI	Class I	Active
Proteus OXK Stained Suspension	R30953801	FDA UDI	Class I	Unknown
PathoDX RSV Control Slides	R62375	FDA UDI	Class I	Active
Proteus OX2 Stained Suspension	R30953601	FDA UDI	Class I	Active
Proteus OXK Agglutinating Serum	R30165901	FDA UDI	Class I	Active
PathoDx Chlamydia trachomatis Direct Specimen	R62220	FDA UDI	Class I	Active
PathoDX Respiratory Mounting Fluid	R62413	FDA UDI	Class I	Active
Proteus OX2 Agglutinating Serum	R30165701	FDA UDI	Class I	Active
Bordetella pertussis Agglutinating Serum	R30165501	FDA UDI	Class I	Active
PathoDx Chlamydia trachomatis Control Slide	R62205	FDA UDI	Class I	Active
Escherichia coli Polyvalent 2 Types O26(B6), O55(B5), O111(B4), O119(B14), O126(	R30954901	FDA UDI	Class I	Active
Thrombo-Wellcotest Glycine Saline	R30853101	FDA UDI	Class II	Unknown
Escherichia coli Polyvalent 4 Types O44:K74(L), O112:K66(B11), O124:K72(B17), O1	R30955101	FDA UDI	Class I	Active

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