Chrysalis Intelligence · Product Codes · LIP

LIP · Unclassified

3 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
3
2021-07-20 → 2024-09-06
Last 12 months
0
Unique sponsors
3
Medical specialty
Review panel
Regulation number
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. 1 0 2024-09-06
Ortho Clinical Diagnostics 1 0 2024-08-28
Roche Diagnostics 1 0 2021-07-20
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.

CodeTypeDescriptionConfidenceRationale
86780 CPT High CPT code for Treponema pallidum (syphilis) antibody detection by immunoassay (ELISA)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-09-06 K241427 Beckman Coulter, Inc. Access Syphilis
2024-08-28 K241534 Ortho Clinical Diagnostics VITROS Immunodiagnostic Products Syphilis Reagent Pack
2021-07-20 K211302 Roche Diagnostics Elecsys Syphilis