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 with immunoturbidimetric method. Use the Calibrator according to the indicated analytical procedure. For professional use only. For in vitro diagnostics use FDA UDI
- Model / Reference
- 11206D FDA UDI
- Description
- Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests with immunoturbidimetric method. Use the Calibrator according to the indicated analytical procedure. For professional use only. For in vitro diagnostics use FDA UDI
Identifiers
- Catalog Number
- 11206D FDA UDI
- Primary DI / UDI-DI
- 08058056680532 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
Yes
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
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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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 027bfaab-4e25-4447-a058-7cf229071d9f 37 fields · synced Jun 8, 2026