Identity
- Trade Name
- AU FDA UDI
- Generic Name
- Prealbumin (transthyretin) IVD, calibrator FDA UDI
- Device Name
- Prealbumin Calibrator FDA UDI
- Model / Reference
- ODR3029 FDA UDI
- Description
- Prealbumin Calibrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590080839 FDA UDI
- 510(k) Number
- K032285 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Prealbumin (transthyretin) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Prealbumin (transthyretin) IVD, calibrator
Au by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prealbumin (transthyretin) IVD, calibrator.
- K-ASSAY® Prealbumin Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- ARCHITECT — Abbott · Class II
- Dimension® PALB Calibrator — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- C.f.a.s. PAC — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott · Class II
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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 2aa92ecb-8f9e-4c9d-9314-8f87f6a38ec1 34 fields · synced Jun 8, 2026