Identity
- Trade Name
- INNOVANCE D-Dimer Controls FDA UDI
- Generic Name
- D-dimer IVD, control FDA UDI
- Device Name
- INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems FDA UDI
- Model / Reference
- 10873855 FDA UDI
- Description
- INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems FDA UDI
Identifiers
- Catalog Number
- 10873855 FDA UDI
- Primary DI / UDI-DI
- 00630414640181 FDA UDI
- 510(k) Number
- K081732 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, control 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, control
INNOVANCE D-Dimer Controls by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 0c36f3b0-5fb6-4766-b513-cfadae84ac90 37 fields · synced Jun 6, 2026