Identity
- Trade Name
- FIB Calibrator FDA UDI
- Generic Name
- Plasma protein IVD, calibrator FDA UDI
- Device Name
- Fibrinogen Reference Plasma 10 x 1 ml FDA UDI
- Model / Reference
- 71-201 FDA UDI
- Description
- Fibrinogen Reference Plasma 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 71-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006191 FDA UDI
- 510(k) Number
- K781880 FDA UDI
- FDA Product Code
- GIS FDA UDI
- GMDN Term
- Plasma protein IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7340 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
No
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
FIB Calibrator by R2 Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K781880 also covers:
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 296d3ed8-cfbf-41d7-98f4-3ea3cf5c102f 35 fields · synced May 30, 2026