Identity
- Trade Name
- Helena Fibrinogen Calibrator FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, calibrator FDA UDI
- Model / Reference
- 5379 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52553790 FDA UDI
- 510(k) Number
- K841020 FDA UDI
- FDA Product Code
- KQJ FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) 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
Yes
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: Fibrinogen assay (factor I) IVD, calibrator
Helena Fibrinogen Calibrator by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibrinogen assay (factor I) IVD, calibrator.
Cleared under the same submission
K841020 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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 8578a836-d8d7-427e-8da6-b20cf7ff2e8c 34 fields · synced Jun 9, 2026