Identity
- Trade Name
- Dade Thrombin Reagent FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, reagent FDA UDI
- Device Name
- Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies FDA UDI
- Model / Reference
- 10873838 FDA UDI
- Description
- Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies FDA UDI
Identifiers
- Catalog Number
- 10873838 FDA UDI
- Primary DI / UDI-DI
- 00630414640372 FDA UDI
- 510(k) Number
- K050928 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
Dade Thrombin Reagent 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
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- 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
- Multifibren® U — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Multifibren U — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K050928 also covers:
- Dade CA System Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade Owren's Veronal Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® CA System Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® Owren's Veronal Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Dade® Thrombin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 54f9f679-04f8-4f14-82d2-a4c64ac81f5a 37 fields · synced May 30, 2026