Chrysalis Intelligence · Product Codes · DFH

DFH · Kappa, Antigen, Antiserum, Control

Immunology · 10 clearances · 5 unique sponsors

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Device class
Class II
Regulation 866.5550
Total clearances
10
2021-07-14 → 2025-12-19
Last 12 months
1
Unique sponsors
5
Classification details
Medical specialty
Immunology
Review panel
IM
Regulation number
866.5550
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Siemens Healthcare Diagnostics Products GmbH 3 0 2022-03-02
Diazyme Laboratories, Inc. 3 1 2025-12-19
Sebia 2 0 2024-02-23
The Binding Site Group , Ltd. 1 0 2025-05-23
The Binding Site, Ltd. 1 0 2024-01-24
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
82785 CPT — Medium Immunoglobulin kappa chains; antigen assay for kappa light chains
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-19 K253358 Diazyme Laboratories, Inc. Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
2025-05-23 K250549 The Binding Site Group , Ltd. Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
2024-02-23 K231601 Sebia FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
2024-01-24 K231290 The Binding Site, Ltd. Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
2022-11-18 K210623 Sebia FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
2022-09-08 K211648 Diazyme Laboratories, Inc. Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
2022-08-04 K220001 Diazyme Laboratories, Inc. Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
2022-03-02 K212379 Siemens Healthcare Diagnostics Products GmbH N Latex FLC kappa, N Latex FLC lambda
2021-10-29 K201496 Siemens Healthcare Diagnostics Products GmbH N Latex FLC kappa, N Latex FLC lambda
2021-07-14 K193047 Siemens Healthcare Diagnostics Products GmbH N Latex FLC kappa, N Latex FLC lambda
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence