Chrysalis Intelligence · Product Codes · CIG

CIG · Diazo Colorimetry, Bilirubin

Clinical Chemistry · 4 clearances · 2 unique sponsors

Device class
Class II
Regulation 862.1110
Total clearances
4
2022-12-29 → 2026-02-27
Last 12 months
1
Unique sponsors
2
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
862.1110
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, Inc. 3 1 2026-02-27
Abbott Ireland Diagnostics Division 1 0 2022-12-29
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
82874 CPT High Standard CPT for bilirubin (total/direct) diazo colorimetric method
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-02-27 K251998 Siemens Healthcare Diagnostics, Inc. Atellica CH Diazo Total Bilirubin (D_TBil)
2023-06-12 K223078 Siemens Healthcare Diagnostics, Inc. Atellica® CH Diazo Direct Bilirubin (D_DBil)
2023-03-20 K222104 Siemens Healthcare Diagnostics, Inc. Atellica® CH Diazo Total Bilirubin (D_TBil)
2022-12-29 K223324 Abbott Ireland Diagnostics Division Total Bilirubin2