SSP HLA-A low
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
by CareDx AB
Identity
- Trade Name
- SSP HLA-A low FDA UDI
- Generic Name
- HLA class I antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- SSP HLA-A low EUDAMED
- Model / Reference
- Olerup SSP EUDAMED101.401-48u EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340035503026 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07340035503026 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
- GMDN Term
- HLA class I antigen tissue typing IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
SSP HLA-A low by CareDx AB — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-07340035503026 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
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Manufacturer
- Manufacturer
- CareDx AB
- EUDAMED SRN
- SE-MF-000040995
Sources (2)
- EUDAMED 6d3c1986-0c02-4b7c-b303-d80d5913ff0f 61 fields · synced Jun 18, 2026
- FDA UDI 7249a588-dbf3-49a2-851c-13f8b4f4234e 32 fields · synced May 30, 2026