Data / Medical devices / United Kingdom / Oxoid, Ltd.
Oxoid, Ltd.: FDA-registered device maker in Basingstoke, Hampshire, United Kingdom, 100 510(k) clearances
Oxoid, Ltd. is registered with the FDA (registration 8010096) in Basingstoke, Hampshire, United Kingdom. It lists 37 device types. The FDA files 100 510(k) clearances under its listings, the newest dated December 5, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8010096
- FEI number
- 3006224287
- Address
- Wade RD., Basingstoke, Hampshire, United Kingdom, RG24 8PW
- Owner or operator
- Thermo Fisher Scientific (2517925)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- June 21, 1978
- Registered through
- 2026
- Brand names listed
- ATM30 AZTREONAM, Antibiotic Medium, Antisera, All Groups, Streptococcus Spp., Antisera, All Types, Escherichia Coli, Antisera, Fluorescent, All Types, Staphylococcus Spp., CEC30 CEFACLOR, CIP5 CIPROFLOXACIN, CM0001B NUTRIENT BROTH, CM0001R NUTRIENT BROTH, CM0003B NUTRIENT AGAR, and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 5, 2025 | K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | JTN | Substantially Equivalent | Thermo Fisher Scientific (Oxoid Ltd.) | accessdata.fda.gov |
| June 12, 2025 | K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | JTN | Substantially Equivalent | Thermo Fisher Scientific (Oxoid Ltd.) | accessdata.fda.gov |
| October 6, 2023 | K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | JTN | Substantially Equivalent | Oxoid Limited (Part of Thermo Fisher Scientific) | accessdata.fda.gov |
| September 15, 2022 | K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | JTN | Substantially Equivalent | Oxoid Limited (Part of Thermo Fisher Scientific) | accessdata.fda.gov |
| October 27, 2021 | K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | JTN | Substantially Equivalent | Oxoid Limited (Part of Thermo Fisher Scientific) | accessdata.fda.gov |
| July 30, 2021 | K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | JTN | Substantially Equivalent | Oxoid Limited (Part of Thermo Fisher Scientific) | accessdata.fda.gov |
| December 4, 2020 | K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | JTN | Substantially Equivalent | Oxoid Limited (Part of Thermo Fisher Scientific) | accessdata.fda.gov |
| September 27, 2018 | K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 | JTN | Substantially Equivalent | Oxoid Limited (Part of Thermo Fisher Scientific) | accessdata.fda.gov |
| March 14, 2007 | K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| March 17, 2006 | K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| February 26, 2004 | K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | LLH | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| November 18, 2003 | K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | MHI | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| April 2, 2002 | K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST | MYI | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| April 24, 2001 | K010537 | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| April 24, 2001 | K010536 | MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| May 22, 2000 | K000930 | GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| May 15, 2000 | K000928 | QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| February 28, 2000 | K993401 | DRYSPOT E.COLI 0157 KIT | GNA | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| March 9, 1999 | K984608 | GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| January 13, 1999 | K984036 | NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| December 11, 1998 | K983718 | MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| November 18, 1998 | K982315 | PROSPECT CAMPYLOBACTER MICROPLATE ASSAY | LQP | Substantially Equivalent | Alexon - Trend, Inc. | accessdata.fda.gov |
| September 22, 1998 | K981734 | VTEC-RPLA SEIKEN | GNA | Substantially Equivalent | Denka Seiken'S | accessdata.fda.gov |
| September 9, 1998 | K982669 | OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 9, 1998 | K982528 | NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 9, 1998 | K982524 | AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 9, 1998 | K982523 | SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 9, 1998 | K982520 | CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 9, 1998 | K982519 | LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 9, 1998 | K982517 | CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 3, 1998 | K982709 | MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY | MHJ | Substantially Equivalent | Alexon - Trend, Inc. | accessdata.fda.gov |
| January 28, 1998 | K971636 | RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| December 23, 1997 | K971637 | COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| December 22, 1997 | K973954 | IMAGEN RESPIRATORY SCREEN | GNW | Substantially Equivalent | Dako Diagnostics , Ltd. | accessdata.fda.gov |
| October 10, 1997 | K973488 | LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| October 6, 1997 | K973487 | CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| September 8, 1997 | K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | JWX | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| August 20, 1997 | K971638 | CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| August 13, 1997 | K971632 | TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| July 3, 1997 | K971635 | AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| July 3, 1997 | K971633 | PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| July 3, 1997 | K971631 | CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Oxoid , Ltd. | accessdata.fda.gov |
| February 7, 1997 | K964495 | CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 7, 1997 | K964492 | CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 7, 1997 | K964491 | NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 7, 1997 | K964490 | AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 7, 1997 | K964489 | CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 7, 1997 | K964487 | IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 6, 1997 | K964512 | CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 6, 1997 | K964501 | SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 6, 1997 | K964496 | CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC | JTN | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
| February 23, 1996 | K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| February 9, 1996 | K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY | MHI | Substantially Equivalent | Alexon Biomedical, Inc. | accessdata.fda.gov |
| January 9, 1995 | K943557 | IMAGEN | GQS | Substantially Equivalent | Dako Diagnostics , Ltd. | accessdata.fda.gov |
| September 9, 1994 | K942098 | PROSPECT GIARDIA | MHI | Substantially Equivalent | Alexon, Inc. | accessdata.fda.gov |
| February 17, 1994 | K930418 | CRYPTO-LEX SYSTEM | GMD | Substantially Equivalent | Trinity Laboratories, Inc. | accessdata.fda.gov |
| November 22, 1993 | K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | GMD | Substantially Equivalent | Alexon Biomedical, Inc. | accessdata.fda.gov |
| November 30, 1992 | K924846 | REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| October 26, 1992 | K924766 | REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 13, 1989 | K892928 | HAEMOPHILUS TEST MEDIUM (AGAR) | JSO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| February 24, 1988 | K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | GNX | Substantially Equivalent | Boots-Celltech Diagnostics, Inc. | accessdata.fda.gov |
| November 6, 1987 | K874303 | STAPHYLASE TEST | LHT | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| August 10, 1987 | K872956 | SORBITOL MACCONKEY AGAR NO. 3 CM 813 | JSI | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| May 8, 1987 | K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | GQN | Substantially Equivalent | Boots-Celltech Diagnostics, Inc. | accessdata.fda.gov |
| March 12, 1987 | K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | LJP | Substantially Equivalent | Boots-Celltech Diagnostics, Inc. | accessdata.fda.gov |
| November 5, 1986 | K862946 | OXOID SIGNAL BLOOD CULTURE SYSTEM | JSG | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 4, 1986 | K855236 | DIAGNOSTIC REAGENT TST-RPLA | GTN | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 4, 1986 | K855235 | DIAGNOSTIC REAGENT PET-RPLA | JSP | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 4, 1986 | K855234 | DIAGNOSTIC REAGENT VET-RPLA | GNA | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 4, 1986 | K855233 | DIAGNOSTIC REAGENT SET-RPLA | GTN | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 11, 1986 | K854929 | OXOID STREPTOCOCAL GROUPING KIT | GTZ | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 4, 1986 | K860153 | OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS | JTN | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| January 3, 1986 | K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST | GQG | Substantially Equivalent | Boots-Celltech Diagnostics, Inc. | accessdata.fda.gov |
| March 20, 1985 | K850658 | CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE | JSG | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| May 11, 1984 | K840332 | CAMPYLOBACTER AGAR BASE | JSJ | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| August 26, 1983 | K832307 | ONPG DISCS | JTO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| August 24, 1983 | K832305 | SPS DISCS | JTO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| September 21, 1982 | K822665 | WILKINS-CHALGREN ANAEROBE BROTH | JSC | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| September 21, 1982 | K822664 | PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPP | JSJ | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| September 21, 1982 | K822659 | YERSINIA AGAR BASE & SUPPLEMENT | JSJ | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| December 31, 1981 | K813509 | METRONIDAZOLE DIAGNOSTIC DISCS | JTO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 6, 1981 | K812894 | VDRL CARBON ANTIGEN | GMQ | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| June 24, 1981 | K811518 | VCNT ANTIBIOTIC SUPPLEMENT | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| June 18, 1981 | K811513 | WILKINS-CHALGREN ANAEROBE AGAR | JSO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| April 14, 1981 | K810932 | VITOX | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| April 14, 1981 | K810931 | SS AGAR (MODIFIED) | JSI | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| December 18, 1980 | K802495 | CLOSTRIDIUM DIFFICILE AGAR BASE | JSJ | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| December 11, 1980 | K802753 | CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 12, 1980 | K802502 | X & V FACTOR DISCS | JTO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 12, 1980 | K802501 | V FACTOR DISCS | JTO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 12, 1980 | K802500 | X-FACTOR DISCS | JTO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 12, 1980 | K802498 | MUELLER HINTON AGAR | JTZ | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| November 12, 1980 | K802496 | OPTOCHIN DIAGNOSTIC DISC | JTO | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 12, 1980 | K800266 | CAMPYLOBACTER GROWTH SUPPLEMENT | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 12, 1980 | K800265 | BORDETELLA SELECTIVE SUPPLEMENT | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 12, 1980 | K800264 | CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 12, 1980 | K800261 | DERMASEL SUPPLEMENT | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 12, 1980 | K800260 | STREPTOCOCCUS SUPPLEMENT | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 12, 1980 | K800258 | STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
| March 12, 1980 | K800253 | MYCOPLASMA SUPPLEMENT G | JSK | Substantially Equivalent | Oxoid U.S.A., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | 96113 | Class II | Ongoing | Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 | Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs. | accessdata.fda.gov |
Compare with other makers
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- All makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Updated December 5, 2025. 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.