Chrysalis Intelligence · Product Codes · LON

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Microbiology · 38 clearances · 7 unique sponsors

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Device class
Class II
Regulation 866.1645
Total clearances
38
2020-02-14 → 2026-04-15
Last 12 months
2
Unique sponsors
7
Classification details
Medical specialty
Microbiology
Review panel
MI
Regulation number
866.1645
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
bioMerieux, Inc. 27 2 2026-04-15
Becton, Dickinson and Company 4 0 2025-08-08
Selux Diagnostics, Inc. 2 0 2023-04-19
Copan Wasp Srl 2 0 2023-12-27
Biomérieux, Inc. 1 0 2022-02-04
Beckman Coulter, Inc. 1 0 2020-08-30
Biomerieux Sa, Inc. 1 0 2023-03-09
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87181 CPT — High Antimicrobial susceptibility test; automated system for short incubation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-15 K260282 bioMerieux, Inc. VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
2026-03-26 K260281 BIOMERIEUX VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
2025-08-21 K251579 bioMerieux, Inc. VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
2025-08-08 K251713 Becton, Dickinson and Company BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
2025-05-19 K250447 Becton, Dickinson and Company BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
2025-03-14 K234012 bioMerieux, Inc. VITEK COMPACT PRO
2025-03-06 K250344 Becton, Dickinson and Company BD Phoenix™ Automated Microbiology System
2024-03-15 K233986 Becton, Dickinson and Company BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
2024-03-11 K234000 bioMerieux, Inc. VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
2023-12-27 K232756 Copan Wasp Srl Colibrí
2023-10-23 K232201 bioMerieux, Inc. VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
2023-07-05 K230864 bioMerieux, Inc. 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
2023-06-26 K222378 bioMerieux, Inc. VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
2023-04-19 K211748 Selux Diagnostics, Inc. Selux AST System; Model AST Gen 1.0
2023-03-09 K222430 Biomerieux Sa, Inc. VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
2023-02-16 K223478 bioMerieux, Inc. 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
2023-02-09 K222073 bioMerieux, Inc. VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
2023-02-03 K223481 bioMerieux, Inc. VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
2023-01-27 K220803 bioMerieux, Inc. 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
2023-01-18 K211759 Selux Diagnostics, Inc. Selux AST System; Model AST Gen 1.0
2022-10-13 K220805 bioMerieux, Inc. VITEK 2 AST-Gram Positive Cefoxitin Screen
2022-10-05 K220546 Copan Wasp Srl Colibrí System
2022-08-08 K212243 bioMerieux, Inc. VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
2022-07-12 K213899 bioMerieux, Inc. 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
2022-06-03 K213931 bioMerieux, Inc. VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence