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Data / Medical devices / United Kingdom / Remel Europe Ltd

Remel Europe Ltd: FDA-registered device maker in Dartford, Kent, United Kingdom, 30 510(k) clearances

Remel Europe Ltd is registered with the FDA (registration 3003750284) in Dartford, Kent, United Kingdom. It lists 68 device types. The FDA files 30 510(k) clearances under its listings, the newest dated April 2, 2002. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Remel Europe Ltd
FDA registration number
3003750284
Address
Remel House, Clipper BLVD. West Crossways, Dartford, Kent, United Kingdom, DA2 6PT
Owner or operator
Thermo Fisher Scientific (2517925)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
June 21, 1978
Registered through
2026
Brand names listed
100% Dehydrant, 60% Dehydrant, 70% Dehydrant, 80% Dehydrant, 95% Dehydrant, ??, A.L.A. Disk, ALN Disk w/Reagent and more

Devices it lists

DeviceProduct codeClassRoleSource
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2GQN2Contract manufactureraccessdata.fda.gov
Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG1Contract manufactureraccessdata.fda.gov
Antigens (Febrile), Agglutination, Brucella Spp.GSO2Manufactureraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Manufacturer, Specification developeraccessdata.fda.gov
Antigens, All Types, Escherichia ColiGMZ1Manufactureraccessdata.fda.gov
Antigens, Cf (Including Cf Control), Influenza Virus A, B, CGNX1Contract manufacturer, Manufactureraccessdata.fda.gov
Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4GQS1Contract manufacturer, Manufactureraccessdata.fda.gov
Antigens, Febrile (Weil-Felix), All GroupsGSZ1Manufactureraccessdata.fda.gov
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.GNC2Manufactureraccessdata.fda.gov
Antigens, Nontreponemal, AllGMQ2Contract manufactureraccessdata.fda.gov
Antisera, Agglutinating, B. ParapertussisGOW1Manufactureraccessdata.fda.gov
Antisera, Agglutinating, B. Pertussis, AllGOY1Manufactureraccessdata.fda.gov
Antisera, All Groups, N. MeningitidisGTJ2Manufactureraccessdata.fda.gov
Antisera, All Groups, Salmonella Spp.GRM2Manufactureraccessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.GTZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Antisera, All Types, Escherichia ColiGNA1Contract manufacturer, Manufactureraccessdata.fda.gov
Antisera, All Types, H. InfluenzaGRP2Manufactureraccessdata.fda.gov
Antisera, All Types, Shigella Spp.GNB2Manufactureraccessdata.fda.gov
Antisera, All Types, Streptococcus PneumoniaeGWC1Manufacturer, Specification developeraccessdata.fda.gov
Antisera, Cf, Influenza Virus A, B, CGNW1Contract manufactureraccessdata.fda.gov
Antisera, Fluorescent, Adenovirus 1-33GNY1Contract manufacturer, Manufactureraccessdata.fda.gov
Antisera, Fluorescent, All Globulins, Proteus Spp.GSY1Manufactureraccessdata.fda.gov
Antisera, Fluorescent, All Types, Escherichia ColiGMY1Manufactureraccessdata.fda.gov
Antisera, Fluorescent, All Types, Staphylococcus Spp.GTN1Manufactureraccessdata.fda.gov
Antisera, Fluorescent, Herpesvirus Hominis 1,2GQL2Manufactureraccessdata.fda.gov
Antisera, Fluorescent, Poliovirus 1-3GOE1Manufactureraccessdata.fda.gov
Antisera, Latex Agglutination, Cryptococcus NeoformansGMD2Contract manufactureraccessdata.fda.gov
Antiserum, Fluorescent, Chlamydia TrachomatisLJP1Contract manufacturer, Manufactureraccessdata.fda.gov
Antiserum, Hai, Mumps VirusGRD1Manufactureraccessdata.fda.gov
Antiserum, Positive And Negative Febrile Antigen Control SerumGSN2Manufactureraccessdata.fda.gov
Antiserum, Vibrio Cholerae, All VarietiesGSQ2Manufactureraccessdata.fda.gov
Campylobacter Spp.LQP1Contract manufactureraccessdata.fda.gov
Cryptosporidium Spp.MHJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Culture Media, Antimycobacteria, Susceptibility TestMJD2Contract manufactureraccessdata.fda.gov
Culture Media, Multiple Biochemical TestJSE1Contract manufactureraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Specification developeraccessdata.fda.gov
Culture Media, Single Biochemical TestJSF1Contract manufactureraccessdata.fda.gov
Device, General Purpose, Microbiology, DiagnosticLIB1Manufacturer, Specification developeraccessdata.fda.gov
Device, Microtiter Diluting/DispensingJTC1Contract manufactureraccessdata.fda.gov
Device, Specimen CollectionLIO1Specification developeraccessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus AntigensPSZ2Contract manufactureraccessdata.fda.gov
Discs, Strips And Reagents, Microorganism DifferentiationJTO1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)LJC1Contract manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.LJZ1Contract manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RotavirusLIQ1Contract manufactureraccessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP2Manufacturer, Specification developeraccessdata.fda.gov
General Purpose ReagentPPM1Manufacturer, Specification developeraccessdata.fda.gov
Giardia Spp.MHI2Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsLRG2Contract manufactureraccessdata.fda.gov
Kit, Anaerobic IdentificationJSP1Contract manufactureraccessdata.fda.gov
Kit, Identification, EnterobacteriaceaeJSS1Contract manufactureraccessdata.fda.gov
Kit, Identification, Glucose NonfermenterJSW1Contract manufactureraccessdata.fda.gov
Kit, Identification, Neisseria GonorrhoeaeJSX1Contract manufactureraccessdata.fda.gov
Kit, Identification, YeastJXB1Contract manufactureraccessdata.fda.gov
Kit, Screening, Staphylococcus AureusJWX1Contract manufacturer, Manufactureraccessdata.fda.gov
Kit, Screening, YeastJXC1Contract manufactureraccessdata.fda.gov
Legionella, Spp., ElisaMJH2Contract manufactureraccessdata.fda.gov
Manual Antimicrobial Susceptibility Test SystemsJWY2Contract manufactureraccessdata.fda.gov
Panels, Test, Susceptibility, AntimicrobialLTT2Contract manufactureraccessdata.fda.gov
Phytohemaglutinin MIBB1Manufactureraccessdata.fda.gov
Reagents, Clostridium Difficile ToxinLLH1Contract manufacturer, Manufactureraccessdata.fda.gov
Respiratory Syncytial Virus, Antigen, Antibody, IfaLKT1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Staphylococcus Aureus Somatic AntigensLHT1Contract manufactureraccessdata.fda.gov
Susceptibility Test Cards, AntimicrobialLTW2Contract manufactureraccessdata.fda.gov
Susceptibility Test Plate, AntifungalNGZ2Contract manufactureraccessdata.fda.gov
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus ColoniesMYI2Specification developeraccessdata.fda.gov
System, Test, Infectious MononucleosisKTN2Contract manufacturer, Manufactureraccessdata.fda.gov
Thyroglobulin, Antigen, Antiserum, ControlDDC2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 2, 2002K011710OXOID PBP2 1 LATEX AGGLUTINATION TESTMYISubstantially EquivalentOxoid , Ltd.accessdata.fda.gov
March 18, 1999K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1LKTSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
April 23, 1998K980507PROSPECT SHIGA TOXIN MICROPLATE ASSAYGMZSubstantially EquivalentAlexon - Trend, Inc.accessdata.fda.gov
December 30, 1997K971663WELLCOLEX E.COLI O157:H7GMZSubstantially EquivalentMurex Biotech , Ltd.accessdata.fda.gov
November 1, 1996K962028WELLCOLEX E-COLI OI57 ZC60GNASubstantially EquivalentMurex Diagnostics, Inc.accessdata.fda.gov
June 1, 1995K945538STAPHAUREX PLUS(TM)JWXSubstantially EquivalentMurex Diagnostics Limitdaccessdata.fda.gov
December 19, 1994K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)LKTSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
January 31, 1992K915203D-DIMER WELLCOTEST (HA10)DAPSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
March 29, 1991K910797STREPTEX ACID EXTRACTION KITGTZSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
December 13, 1990K904167PATHODX HERPES TYPINGGQLSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
April 16, 1990K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTLJPSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
February 1, 1990K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1LJPSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
January 11, 1990K895461WELLCOLEX COLOUR SHIGELLA TEST ZC51GNBSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
February 16, 1989K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50GRMSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
April 7, 1988K881247MONO-PHILEKTNSubstantially EquivalentBio Diagnostic Systems, Inc.accessdata.fda.gov
June 17, 1987K871831PATHO DX LATEX AGGLUTINATION STREP GROUPING KITGTZSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
April 20, 1987K864998IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KITJSMSubstantially EquivalentBoots-Celltech Diagnostics, Inc.accessdata.fda.gov
August 4, 1986K862607IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KITLIOSubstantially EquivalentBoots-Celltech Diagnostics, Inc.accessdata.fda.gov
February 4, 1986K854852WELLCOGEN BACTERIAL ANTIGEN KITGTJSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
February 4, 1986K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24GTJSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
June 4, 1985K844762MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51GTJSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
May 22, 1985K851949STAPHAUREX ZL30GTNSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
August 15, 1984K842828STREPTEX ZL01JTOSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
July 2, 1984K842383PATHO DX LATEX AGGLUTINATION STREP AGTZSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
May 2, 1984K841376WELLCOGEN S. PNEUMONIAEGWCSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
January 10, 1984K833077WELLCOGEN H. INFLUENZAL ZL21GRDSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
January 10, 1984K833063WELLCOGEN N. MENINGITIDIS A,C,Y W135GTJSubstantially EquivalentWellcome Diagnosticsaccessdata.fda.gov
February 18, 1982K820069WELLCOGEN GROUP BGTZSubstantially EquivalentBurroughs Wellcome Co.accessdata.fda.gov
June 14, 1978K780873THYMUNE-MDDCSubstantially EquivalentBurroughs Wellcome Co.accessdata.fda.gov
August 25, 1977K771562AGGLUTINATING SERUM W135GTJSubstantially EquivalentBurroughs Wellcome Co.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 17, 202699450Class IIOngoingThermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnosticsCertain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.accessdata.fda.gov
March 25, 202698652Class IIOngoingOxoid Agglutinating Sera, Salmonella 9-0 R30957301Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.accessdata.fda.gov
July 23, 202086109Class IITerminatedThermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically iThermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3accessdata.fda.gov

Compare with other makers

Updated August 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.