Identity
- Trade Name
- PlasmaRef ARN FDA UDI
- Generic Name
- Plasma protein IVD, calibrator FDA UDI
- Device Name
- Assayed Reference Plasma 10 x 1 ml FDA UDI
- Model / Reference
- 33-201 FDA UDI
- Description
- Assayed Reference Plasma 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 33-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006177 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Plasma protein IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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: Plasma protein IVD, calibrator
PlasmaRef ARN by R2 Diagnostics, Inc. — 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
- R2 Diagnostics, Inc.
Sources (1)
- FDA UDI 9398dbbd-b5bb-4b1e-ae63-d7ae41644fc9 34 fields · synced Jun 8, 2026