Identity
- Trade Name
- MedTest DX Total Iron / BS480 FDA UDI
- Generic Name
- Iron IVD, kit, spectrophotometry FDA UDI
- Device Name
- Total Iron, for the quantitative determination of iron in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. Size: 5 x 58ml, 5 x 12ml FDA UDI
- Model / Reference
- IRO480 FDA UDI
- Description
- Total Iron, for the quantitative determination of iron in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. Size: 5 x 58ml, 5 x 12ml FDA UDI
Identifiers
- Catalog Number
- IRO480 FDA UDI
- Primary DI / UDI-DI
- 00817439020932 FDA UDI
- FDA Product Code
- JIY FDA UDI
- GMDN Term
- Iron IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1410 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
MedTest DX Total Iron / BS480 by Medtest DX — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtest DX
Sources (1)
- FDA UDI 2be3d2fd-16fb-4d64-a166-37920076153f 37 fields · synced Jun 6, 2026