Identity
- Trade Name
- VisuCon-F Frozen Normal Control Plasma FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- Intended for use in the quality control of coagulation assays in the normal range. FDA UDI
- Model / Reference
- FRNCP0125 FDA UDI
- Description
- Intended for use in the quality control of coagulation assays in the normal range. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10629009051256 FDA UDI
- 510(k) Number
- K091284 FDA UDI
- FDA Product Code
- GGN 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
VisuCon-F Frozen Normal Control Plasma by Affinity Biologicals Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple coagulation factor IVD, control.
- directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Coagulation S.A.R.P (Specialty Assayed Reference Plasma) — Helena Laboratories, Corp. · Class II
- Dade Ci-Trol Coagulation Control Level 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- CRYOcheck™ Abnormal 1 Reference Control — Precision Biologic · Class II
- JAS Diagnostics — Drew Scientific , Ltd.
- CueSee® Coag — Eurotrol B.V. · Class II
- COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I
Cleared under the same submission
K091284 also covers:
- Visu-Cal F Frozen Calibrator Plasma — Affinity Biologicals Inc
- VisuCal-F Frozen Calibrator Plasma — Affinity Biologicals Inc
- VisuCon-F Frozen Abnormal Control Plasma — Affinity Biologicals Inc
- VisuCon-F Frozen Abnormal Control Plasma — Affinity Biologicals Inc
- VisuCon-F Frozen Calibrator Plasma — Affinity Biologicals Inc
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
- Affinity Biologicals Inc
Sources (1)
- FDA UDI 32782de4-e80c-4600-a337-a06d7a76945b 36 fields · synced May 31, 2026