Identity
- Trade Name
- PlasmaCon L2 FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- Abnormal Control L-2 10 x 1 ml FDA UDI
- Model / Reference
- 32-201 FDA UDI
- Description
- Abnormal Control L-2 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 32-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006085 FDA UDI
- 510(k) Number
- K062306 FDA UDI
- FDA Product Code
- GGC FDA UDIGIZ FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control 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
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: Multiple coagulation factor IVD, control
PlasmaCon L2 by R2 Diagnostics, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Multiple coagulation factor IVD, control.
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Cleared under the same submission
K062306 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (2)
- FDA UDI f812578d-a4b7-4e2b-b7f2-e9731fec1ef5 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026