Remel Europe Ltd.
DARTFORD, KENT Kent, GB
REMEL EUROPE LTD appears in FDA device records in DARTFORD, KENT Kent, GB. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003750284 | 3003750284 | REMEL EUROPE LTD | REMEL HOUSE, CLIPPER BLVD., DARTFORD, KENT DA2 6PT GB | 2026 | and 58 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GSOAntigens (Febrile), Agglutination, Brucella Spp.
- GTYAntigens, All Groups, Streptococcus Spp.
- GMZAntigens, All Types, Escherichia Coli
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- GSZAntigens, Febrile (Weil-Felix), All Groups
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- GMQAntigens, Nontreponemal, All
- GOWAntisera, Agglutinating, B. Parapertussis
- GOYAntisera, Agglutinating, B. Pertussis, All
- GTJAntisera, All Groups, N. Meningitidis
- GRMAntisera, All Groups, Salmonella Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- GNAAntisera, All Types, Escherichia Coli
- GRPAntisera, All Types, H. Influenza
- GNBAntisera, All Types, Shigella Spp.
- GWCAntisera, All Types, Streptococcus Pneumoniae
- GNWAntisera, Cf, Influenza Virus A, B, C
- GNYAntisera, Fluorescent, Adenovirus 1-33
- GSYAntisera, Fluorescent, All Globulins, Proteus Spp.
- GMYAntisera, Fluorescent, All Types, Escherichia Coli
- GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- GOEAntisera, Fluorescent, Poliovirus 1-3
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- GRDAntiserum, Hai, Mumps Virus
- GSNAntiserum, Positive And Negative Febrile Antigen Control Serum
- GSQAntiserum, Vibrio Cholerae, All Varieties
- LQPCampylobacter Spp.
- JSECulture Media, Multiple Biochemical Test
- JSMCulture Media, Non-Propagating Transport
- JSFCulture Media, Single Biochemical Test
- LIBDevice, General Purpose, Microbiology, Diagnostic
- JTCDevice, Microtiter Diluting/Dispensing
- LIODevice, Specimen Collection
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- JSPKit, Anaerobic Identification
- JSSKit, Identification, Enterobacteriaceae
- JSWKit, Identification, Glucose Nonfermenter
- JSXKit, Identification, Neisseria Gonorrhoeae
- JXBKit, Identification, Yeast
- JWXKit, Screening, Staphylococcus Aureus
- JXCKit, Screening, Yeast
- JWYManual Antimicrobial Susceptibility Test Systems
- LTTPanels, Test, Susceptibility, Antimicrobial
- IBBPhytohemaglutinin M
- LLHReagents, Clostridium Difficile Toxin
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- LHTStaphylococcus Aureus Somatic Antigens
- LTWSusceptibility Test Cards, Antimicrobial
- KTNSystem, Test, Infectious Mononucleosis
- DDCThyroglobulin, Antigen, Antiserum, Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2927-2026 | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics | Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds. | Class II | Open, Classified | |
| Z-1923-2026 | Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 | Affected 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. | Class II | Open, Classified | |
| Z-2920-2020 | Thermo 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 identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes. | Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain