Atellica CH Prealbumin (PALB)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Atellica CH Prealbumin (PALB) EUDAMEDFDA UDI
- Generic Name
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_PALB EUDAMEDAtellica CH Prealbumin (PALB) FDA UDI
- Model / Reference
- 11537217 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_B_REAG_PALB EUDAMED
- Description
- Atellica CH Prealbumin (PALB) FDA UDI
Identifiers
- Catalog Number
- 11537217 FDA UDI
- Primary DI / UDI-DI
- 00630414614939 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686902245VH EUDAMED
- Unit of Use DI
- 00630414313412 EUDAMED
- FDA Product Code
- JZJ FDA UDI
- EMDN Code
- W0102010305 PRE-ALBUMIN / TRANSTHYRETIN EUDAMED
- GMDN Term
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5060 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
Atellica CH Prealbumin (PALB) by Siemens Healthcare Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry.
- VITROS — Ortho-Clinical Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Prealbumin — Roche Diagnostics Corp. · Class I
- Alinity — Abbott · Class I
- Alinity — ABBOTT IRELAND · Class I
- ABX PENTRA PREALBUMIN — Horiba Abx · Class I
- Yumizen C1200 Prealbumin — Horiba Abx · Class I
- Prealbumin — Roche Diagnostics Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| 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
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 1ccd63fb-8e50-4ad6-a2ee-e20103da2326 36 fields · synced Jul 26, 2026
- EUDAMED 881d82ea-24d3-4059-be10-b8826d6adc7d 61 fields · synced Jul 26, 2026