Identity
- Trade Name
- Atellica CH PreAlb FDA UDI
- Generic Name
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Prealbumin (PreAlb) Atellica CH - RGT 400T FDA UDI
- Model / Reference
- 11097617 FDA UDI
- Description
- Prealbumin (PreAlb) Atellica CH - RGT 400T FDA UDI
Identifiers
- Catalog Number
- 11097617 FDA UDI
- Primary DI / UDI-DI
- 00630414596259 FDA UDI
- 510(k) Number
- K000661 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
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
Atellica CH PreAlb by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — 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
Cleared under the same submission
K000661 also covers:
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 5f843cda-69f7-4ed8-b2c4-799b540d3369 37 fields · synced May 30, 2026