Identity
- Trade Name
- Plasmaproteins Cal 3x FDA UDI
- Generic Name
- Plasma protein IVD, calibrator FDA UDI
- Device Name
- Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the calibrator according to the indicated analytical procedure. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- A26854 FDA UDI
- Description
- Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the calibrator according to the indicated analytical procedure. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- A26854 FDA UDI
- Primary DI / UDI-DI
- 08058056681300 FDA UDI
- 510(k) Number
- K081533 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Plasma protein 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Category: Plasma protein IVD, calibrator
Plasmaproteins Cal 3x by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plasma protein IVD, calibrator.
- BIOPHEN PLASMA CALIBRATOR — HYPHEN BIOMED · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Cfas PUC — Roche Diagnostics Corp. · Class II
- Elecsys IgE CalSet — Roche Diagnostics Corp. · Class II
- PlasmaRef ARN — R2 DIAGNOSTICS, INC. · Class II
- N Protein Standard UY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- DImension Vista® Protein 2 Calibrator — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Preciset RF — Roche Diagnostics Corp. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 2682a975-64d0-420c-bd35-b1048885c251 38 fields · synced May 30, 2026