Chrysalis Intelligence · Product Codes · MRG

MRG · System, Test, Vitamin D

Clinical Chemistry · 5 clearances · 5 unique sponsors

Device class
Class II
Regulation 862.1825
Total clearances
5
2020-05-29 → 2024-04-12
Last 12 months
0
Unique sponsors
5
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
862.1825
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. 1 0 2020-05-29
Beckman Coulter, Inc. 1 0 2023-01-19
Immunostics Inc., 1 0 2023-09-22
Shenzhen New Industries Biomedical Engineering Co., Ltd. 1 0 2024-04-12
Roche Diagnostics 1 0 2021-09-01
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
82652 CPT High Standard code for vitamin D testing (25-hydroxy vitamin D)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-04-12 K232587 Shenzhen New Industries Biomedical Engineering Co., Ltd. MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
2023-09-22 K221817 Immunostics Inc., ALFIS Vitamin D, ALFIS-3 Analyzer
2023-01-19 K223503 Beckman Coulter, Inc. Access 25(OH) Vitamin D Total
2021-09-01 K210901 Roche Diagnostics Elecsys Vitamin D total III
2020-05-29 K200509 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Vitamin D Total (VitD)