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AIA-PACK FER Calibration Verification Test Set
FDA UDIClass II (US FDA UDI)
by Tosoh Corp.
Identity
- Trade Name
- AIA-PACK FER Calibration Verification Test Set FDA UDI
- Generic Name
- Ferritin IVD, control FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189212251 FDA UDI
- FDA Product Code
- DBF FDA UDI
- GMDN Term
- Ferritin IVD, control 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
Yes
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, control
AIA-PACK FER Calibration Verification Test Set by Tosoh Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ferritin IVD, control.
- ADVIA Centaur® FER MCM — Siemens Healthcare Diagnostics · Class I
- IMMULITE® Systems FER Calibration Verification Material Ferritin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Alinity — ABBOTT IRELAND · Class I
- Atellica IM Fer MCM — Siemens Healthcare Diagnostics · Class I
- Diazyme — Diazyme Laboratories, Inc.
- VITROS — Ortho-Clinical Diagnostics · Class I
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
- Tosoh Corp.
Sources (1)
- FDA UDI a22dfdf3-3c61-4c66-9ad7-704da0cfbbf9 34 fields · synced Jun 8, 2026