Identity
- Trade Name
- Asserachrom® D-Di EUDAMEDFDA UDI
- Generic Name
- D-dimer IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Asserachrom® D-Di EUDAMED
- Model / Reference
- 00947 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450009477 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03607450009477 EUDAMED
- 510(k) Number
- K862156 FDA UDI
- FDA Product Code
- DAP FDA UDI
- EMDN Code
- W0103020503 D-DIMER EUDAMED
- GMDN Term
- D-dimer IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7320 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Asserachrom® D-Di by Diagnostica Stago — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03607450009477 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 4935a58f-c17c-49b4-b161-dede3bde3af1 61 fields · synced Jul 19, 2026
- FDA UDI 39140ace-225f-4e9b-8de2-d3862f13b489 34 fields · synced May 30, 2026