Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE Hampshire, GB
OXOID, LTD. appears in FDA device records in BASINGSTOKE, HAMPSHIRE Hampshire, GB. FDA records list 36 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 36 510(k) clearances for Oxoid, Ltd. between 1997 and 2007. The busiest year on record is 1997, with 11. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 11 |
| 1998 | 11 |
| 1999 | 4 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K042157 | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST | MYI | Substantially Equivalent | |
| K012588 | OXOID PYLORI TEST KIT, MODEL DR0130M | LYR | Substantially Equivalent | |
| K010537 | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K010536 | MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K000930 | GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K000928 | QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K993401 | DRYSPOT E.COLI 0157 KIT | GNA | Substantially Equivalent | |
| K984513 | TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K984608 | GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | KTN | Substantially Equivalent | |
| K984036 | NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K983718 | MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982669 | OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982528 | NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982526 | SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982524 | AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982523 | SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982520 | CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982519 | LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K982517 | CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K971636 | RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K974394 | ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K971637 | COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K973479 | CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K973489 | LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K973488 | LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K973487 | CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | JWX | Substantially Equivalent | |
| K971638 | CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K971632 | TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K971635 | AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K971633 | PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K971631 | CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010096 | 3006224287 | OXOID, LTD. | WADE RD., BASINGSTOKE, HAMPSHIRE RG24 8PW GB | 2026 | and 27 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
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- GMQAntigens, Nontreponemal, All
- GRMAntisera, All Groups, Salmonella Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- GNAAntisera, All Types, Escherichia Coli
- GNWAntisera, Cf, Influenza Virus A, B, C
- GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- LQPCampylobacter Spp.
- MHJCryptosporidium Spp.
- JSACulture Media, Antibiotic Assay
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- JSCCulture Media, General Nutrient Broth
- JSHCulture Media, Non-Selective And Differential
- JSGCulture Media, Non-Selective And Non-Differential
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- KZJDevice, Gas Generating
- LIBDevice, General Purpose, Microbiology, Diagnostic
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- MHIGiardia Spp.
- LQMGram Negative Identification Panel
- LQLGram Positive Identification Panel
- LYRHelicobacter Pylori
- JSPKit, Anaerobic Identification
- JWXKit, Screening, Staphylococcus Aureus
- MJHLegionella, Spp., Elisa
- LLHReagents, Clostridium Difficile Toxin
- LHTStaphylococcus Aureus Somatic Antigens
- JSKSupplement, Culture Media
- JTNSusceptibility Test Discs, Antimicrobial
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
- KTNSystem, Test, Infectious Mononucleosis
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1075-2025 | Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 | Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain