Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- VITROS Chemistry Products PALB Reagent FDA UDI
- Model / Reference
- 6801741 FDA UDI
- Description
- VITROS Chemistry Products PALB Reagent FDA UDI
Identifiers
- Catalog Number
- 6801741 FDA UDI
- Primary DI / UDI-DI
- 10758750006908 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
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
Vitros by Ortho-Clinical Diagnostics — 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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- Prealbumin — Roche Diagnostics Corp. · Class I
- 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
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 85c4481c-5e95-467f-bd35-1b47e6ed79ca 35 fields · synced Jun 6, 2026