Identity
- Trade Name
- INNOVANCE® D-Dimer FDA UDI
- Generic Name
- D-dimer IVD, kit, agglutination FDA UDI
- Device Name
- For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems FDA UDI
- Model / Reference
- 10445982 FDA UDI
- Description
- For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems FDA UDI
Identifiers
- Catalog Number
- OPBP11 FDA UDI
- Primary DI / UDI-DI
- 00842768022821 FDA UDI
- 510(k) Number
- K093626 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7320 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: D-dimer IVD, kit, agglutination
INNOVANCE® D-Dimer by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as D-dimer IVD, kit, agglutination.
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- D-Di Test® — DIAGNOSTICA STAGO, INC. · Class II
- HemosIL D-Dimer HS 500 — INSTRUMENTATION LABORATORY COMPANY · Class II
- STA® - Liatest® D-Di — DIAGNOSTICA STAGO, INC. · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- HemosIL AcuStar D-Dimer — INSTRUMENTATION LABORATORY COMPANY · Class II
- DIMERTEST Latex assay — Biomedica ADI Inc. · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · 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 bc9545c3-ddbe-455c-8387-eace164edada 37 fields · synced May 31, 2026