Identity
- Trade Name
- PlasmaRef ARL-2 FDA UDI
- Generic Name
- Plasma protein IVD, calibrator FDA UDI
- Device Name
- Assayed Reference Plasma L-2 10 x 1 ml FDA UDI
- Model / Reference
- 35-201 FDA UDI
- Description
- Assayed Reference Plasma L-2 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 35-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006184 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 ARL-2 by R2 Diagnostics, Inc. — 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
- 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
- N Protein Standard SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
- R2 Diagnostics, Inc.
Sources (1)
- FDA UDI dbf14736-1b80-4f11-a20c-7729d8a59e73 34 fields · synced May 30, 2026