LTT · Panels, Test, Susceptibility, Antimicrobial

Device class

Class II

Regulation 866.1640

Total clearances

2020-03-03 → 2025-08-20

Last 12 months

Unique sponsors

Classification details

Medical specialty

Microbiology

Review panel

Regulation number

866.1640

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Beckman Coulter, Inc.	7	0	2025-08-20

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.

Code	Type	Description	Confidence	Rationale
87181	CPT	—	High	Antimicrobial susceptibility determination, each antibiotic tested
87184	CPT	—	Medium	Susceptibility studies, disc method, per plate (12 or fewer agents)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-08-20	K243804	Beckman Coulter, Inc.	MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
2025-08-15	K250036	Beckman Coulter, Inc.	MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
2025-07-18	K250084	Beckman Coulter, Inc.	MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
2020-11-16	K202343	Beckman Coulter, Inc.	MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
2020-06-29	K201423	Beckman Coulter, Inc.	MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
2020-03-18	K193536	Beckman Coulter, Inc.	MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
2020-03-03	K193358	Beckman Coulter, Inc.	MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)