Chrysalis Intelligence · Product Codes · CIX

CIX · Bromcresol Green Dye-Binding, Albumin

Clinical Chemistry · 3 clearances · 3 unique sponsors

Device class
Class II
Regulation 862.1035
Total clearances
3
2021-09-21 → 2026-01-09
Last 12 months
1
Unique sponsors
3
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
862.1035
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
Abbott Ireland Diagnostics Division 1 0 2021-11-23
Truvian Health 1 1 2026-01-09
Medicon Hellas S.A 1 0 2021-09-21
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
82040 CPT Medium Albumin quantification; dye-binding method is standard albumin assay approach
82042 CPT Medium Albumin, serum, urine or other body fluid; quantitative
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-01-09 K251157 Truvian Health Core Metabolic
2021-11-23 K203248 Abbott Ireland Diagnostics Division Albumin BCG2
2021-09-21 K200898 Medicon Hellas S.A Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin