Medical device manufacturer
bioMerieux, Inc.
bioMerieux, Inc. holds 261 FDA 510(k) clearances across 46 product codes. Median elapsed review time is 60 days. openFDA lists 633 recall records naming the company. FDA publishes it under 23 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 261
- Product codes
- 46
- Median review
- 60 days
- Recall records
- 633
How does FDA spell bioMerieux, Inc.?
FDA publishes this company under 23 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| BIOMERIEUX | device/510k | normalised |
| BIOMERIEUX SA | device/registrationlisting | normalised |
| BIOMERIEUX, INC. | device/registrationlisting | normalised |
| BIOMERIEUX, INC. | device/recall | normalised |
| BioMerieux SA | device/enforcement | normalised |
| BioMerieux SA | device/recall | normalised |
| BioMerieux SA | device/registrationlisting | normalised |
| Biomerieux | device/enforcement | normalised |
Showing 8 of 23.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does bioMerieux, Inc. file in?
46 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 116 | 79 days | |
| JSJ | Culture Media, Selective And Non-Differential | 18 | 30 days | |
| JSG | Culture Media, Non-Selective And Non-Differential | 13 | 47 days | |
| JSH | Culture Media, Non-Selective And Differential | 12 | 47 days | |
| MDB | System, Blood Culturing | 12 | 40 days | |
| JSI | Culture Media, Selective And Differential | 11 | 29 days | |
| NGZ | Susceptibility Test Plate, Antifungal | 10 | 232 days | |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 8 | 66 days | |
| JSF | Culture Media, Single Biochemical Test | 7 | 56 days | |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 4 | 204 days | |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 4 | 98 days | |
| KZI | Culture Media, Enriched | 3 | 29 days | |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 31 days | |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 29 days | |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 16 days | |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 231 days | |
| LLH | Reagents, Clostridium Difficile Toxin | 2 | 70 days | |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | 407 days | |
| LYR | Helicobacter Pylori | 2 | 147 days | |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 82 days | |
| QBN | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | 2 | 205 days | |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 83 days | |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 258 days | |
| GHH | Fibrin Split Products | 1 | 61 days | |
| GKG | Centrifuge, Hematocrit | 1 | 78 days |
Showing the 25 they file in most, of 46.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has bioMerieux, Inc. had a recall?
openFDA lists 633 recall records naming this company across its whole history, of which 2 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2715-2026Class IIOpen, ClassifiedLON
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Z-1236-2026Class IIOpen, ClassifiedLTW
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Z-2671-2025Class IIOpen, ClassifiedLON
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Z-1464-2024Class IOpen, ClassifiedLON
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Z-1201-2023Class IIOpen, ClassifiedOUG
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Showing the 5 most recently initiated of 633.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has bioMerieux, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | SAN | 169 | |
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | JWY | 69 | |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | LON | 76 | |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | LON | 56 | |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | LON | 90 | |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | JWY | 83 | |
| K234012 | VITEK COMPACT PRO | LON | 451 | |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | NGZ | 265 | |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | NGZ | 260 | |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | QAT | 90 |
Source: openFDA device/510k · retrieved
Where is bioMerieux, Inc. registered?
FDA lists 9 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what bioMerieux, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.