Identity
- Trade Name
- Yumizen C1200 Ferritin Cal FDA UDI
- Generic Name
- Ferritin IVD, calibrator FDA UDI
- Model / Reference
- 1300023902 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230007549 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Ferritin IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ferritin IVD, calibrator
Yumizen C1200 Ferritin Cal by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ferritin IVD, calibrator.
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Elecsys Ferritin CalSet — Roche Diagnostics Corp. · Class II
- Dimension® FERR Calibrator — Siemens Healthcare Diagnostics · Class II
- K-ASSAY® Ferritin Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Alinity — ABBOTT IRELAND · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI 65645038-a2a7-4591-b7a2-eaf73293e4fc 32 fields · synced May 31, 2026