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bioMerieux, Inc.

FDA 510(k) & PMA Approved Devices — 66 products

Total Devices66
Categories13
Latest Approval2026-04-15
TypeNumberDevice NameCodeDate
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
510(k) K212461 VITEK MS PRIME QBN 2022-03-15 View

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