Identity
- Trade Name
- Multifibren® U FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, reagent FDA UDI
- Device Name
- Quantitative determination of fibrinogen in plasma FDA UDI
- Model / Reference
- 10446689 FDA UDI
- Description
- Quantitative determination of fibrinogen in plasma FDA UDI
Identifiers
- Catalog Number
- OWZG19 FDA UDI
- Primary DI / UDI-DI
- 00842768017865 FDA UDI
- 510(k) Number
- K934326 FDA UDI
- FDA Product Code
- KQJ FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) IVD, reagent 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, reagent
Multifibren® U by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibrinogen assay (factor I) IVD, reagent.
- Helena Thrombin Reagent — Helena Laboratories, Corp. · Class II
- K-ASSAY® Fibrinogen Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- Dade® Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Kaolin Suspension — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Dade Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Multifibren U — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 99d58bde-f5e4-42bd-a6d6-bc0d7bfad906 37 fields · synced May 31, 2026