Identity
- Trade Name
- Prealbumin FDA UDI
- Generic Name
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 5950902190 FDA UDI
Identifiers
- Catalog Number
- 5950902190 FDA UDI
- Primary DI / UDI-DI
- 04015630928804 FDA UDI
- FDA Product Code
- JZJ FDA UDI
- GMDN Term
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5060 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
Yes
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: Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
Prealbumin by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry.
- Atellica CH Prealbumin (PALB) — Siemens Healthcare Diagnostics · Class I
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- Alinity — Abbott · Class I
- Alinity — ABBOTT IRELAND · Class I
- ABX PENTRA PREALBUMIN — Horiba Abx · Class I
- ADVIA® Chemistry PREALB Prealbumin Reagents — Siemens Healthcare 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 I | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI f6064704-927e-41e3-9619-b01c7dc4a274 33 fields · synced May 31, 2026