bioMerieux, Inc.
FDA 510(k) & PMA Approved Devices — 67 products
Total Devices67
Categories14
Latest FDA decision2026-07-08
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | SAN | 2026-07-08 | View |
| 510(k) | K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | LON | 2026-04-15 | View |
| 510(k) | K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | LON | 2025-08-21 | View |
| 510(k) | K234012 | VITEK COMPACT PRO | LON | 2025-03-14 | View |
| 510(k) | K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | NGZ | 2024-06-12 | View |
| 510(k) | K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | NGZ | 2024-06-07 | View |
| 510(k) | K240279 | VIDAS TBI (GFAP, UCH-L1) | QAT | 2024-05-01 | View |
| 510(k) | K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | LON | 2024-03-11 | View |
| 510(k) | K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | LON | 2023-10-23 | View |
| 510(k) | K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | LON | 2023-07-05 | View |
| 510(k) | K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | LON | 2023-06-26 | View |
| 510(k) | K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | LON | 2023-02-16 | View |
| 510(k) | K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | LON | 2023-02-09 | View |
| 510(k) | K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | LON | 2023-02-03 | View |
| 510(k) | K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin | LON | 2023-01-27 | View |
| 510(k) | K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | LON | 2022-10-13 | View |
| 510(k) | K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | LON | 2022-08-08 | View |
| 510(k) | K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin | LON | 2022-07-12 | View |
| 510(k) | K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | LON | 2022-06-03 | View |
| 510(k) | K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | LON | 2022-04-14 | View |
No matching devices.
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