Identity
- Trade Name
- Dade® Data-Fi® Abnormal Fibrinogen Control FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, control FDA UDI
- Device Name
- Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range FDA UDI
- Model / Reference
- 10445719 FDA UDI
- Description
- Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range FDA UDI
Identifiers
- Catalog Number
- B4233-22 FDA UDI
- Primary DI / UDI-DI
- 00842768003936 FDA UDI
- 510(k) Number
- K811069 FDA UDI
- FDA Product Code
- KQJ FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) IVD, control 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
No
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: Fibrinogen assay (factor I) IVD, control
Dade® Data-Fi® Abnormal Fibrinogen Control by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Fibrinogen assay (factor I) IVD, control.
- Fibrinogen / FITC control slides — BIO SB, INC. · Class I
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- Fibrinogen control slides — BIO SB, INC. · Class I
- CRYOcheck™ Low Fibrinogen Control — Precision Biologic · Class II
- Fibrinogen Control Slides — BIO SB, INC. · Class I
- K-ASSAY® Fibrinogen Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K811069 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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI ead29129-8277-4587-a17d-991b77ce14f1 37 fields · synced May 31, 2026