Identity
- Trade Name
- PREALBUMIN (PreALB) FDA UDI
- Generic Name
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- A prealbumin (transthyretin) test system is a device intended for the quantitative in vitro determination of prealbumin (transthyretin) concentration in serum. FDA UDI
- Model / Reference
- PA3843 FDA UDI
- Description
- A prealbumin (transthyretin) test system is a device intended for the quantitative in vitro determination of prealbumin (transthyretin) concentration in serum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273204759 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
Yes
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 (PreALB) by Randox Laboratories, Ltd. — 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
- VITROS — Ortho-Clinical Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Atellica CH PreAlb — Siemens Healthcare Diagnostics · Class I
- Prealbumin — Roche Diagnostics Corp. · Class I
- Alinity — Abbott · Class I
- Alinity — ABBOTT IRELAND · Class I
- ABX PENTRA PREALBUMIN — Horiba Abx · 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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 3fd4a494-639b-4988-b815-a93b6dbe8867 35 fields · synced Jun 8, 2026