Chrysalis Intelligence · Product Codes · CDZ

CDZ · Unclassified

6 clearances · 4 unique sponsors

Device class
Regulation —
Total clearances
6
2020-10-15 → 2026-04-15
Last 12 months
1
Unique sponsors
4
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
Immunodiagnostic Systems Limited 2 1 2026-04-15
Beckman Coulter, Inc. 2 0 2024-02-08
DiaSorin, Inc. 1 0 2020-10-15
Roche Diagnostics 1 0 2022-05-06
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
84403 CPT High Standard CPT for testosterone (total and free) RIA/immunoassay
84404 CPT High Standard CPT for free testosterone measurement
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-15 K252728 Immunodiagnostic Systems Limited IDS-iSYS Total Testosterone
2024-10-23 K240865 Immunodiagnostic Systems Limited IDS-iSYS Free Testosterone
2024-02-08 K233480 Beckman Coulter, Inc. Access SHBG
2023-01-13 K223405 Beckman Coulter, Inc. Access Testosterone
2022-05-06 K211685 Roche Diagnostics Elecsys Testosterone II
2020-10-15 K201908 DiaSorin, Inc. LIAISON Testosterone xt