Identity
- Trade Name
- Yumizen C1200 Ferritin FDA UDI
- Generic Name
- Ferritin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 1300023880 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230007327 FDA UDI
- 510(k) Number
- K191562 FDA UDI
- FDA Product Code
- DBF FDA UDI
- GMDN Term
- Ferritin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5340 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
No
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, kit, nephelometry/turbidimetry
Yumizen C1200 Ferritin by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ferritin IVD, kit, nephelometry/turbidimetry.
- N Latex Ferritin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Tina-quant Ferritin Gen.4 — Roche Diagnostics Corp. · Class II
- ADVIA® Chemistry FRT Ferritin Reagents — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K191562 also covers:
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 |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI 8e5bc435-988c-4205-ba34-f97e78153686 33 fields · synced May 31, 2026