Ssp Hla-B*82
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
by CareDx AB
Identity
- Trade Name
- SSP HLA-B*82 FDA UDI
- Generic Name
- HLA class I antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- SSP HLA-B*82 EUDAMED
- Model / Reference
- Olerup SSP EUDAMED101.552-06u EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340035504986 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07340035504986 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-B*82 by CareDx AB — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
- LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit — ONE LAMBDA, INC. · Class C
- LABType™ HD Class I B Locus Typing Test - 20 tests — ONE LAMBDA, INC. · U
- HLA Class I Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody — ONE LAMBDA, INC. · U
- Micro SSP™ AmbiStrips™ HLA Class I - A0101N — ONE LAMBDA, INC. · U
- LABType™ SSO Class I B7 Supplement Typing Test — ONE LAMBDA, INC. · U
- Lambda Monoclonal Trays™ First HLA Class II - 60 well — ONE LAMBDA, INC. · U
- Micro SSP™ AmbiStrips™ HLA Class I - B27+ B73 — ONE LAMBDA, INC. · U
- SeCore™ B Locus Sequencing Kit, Single Amplification — ONE LAMBDA, INC. · U
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-07340035504986 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CareDx AB
- EUDAMED SRN
- SE-MF-000040995
Sources (2)
- EUDAMED 616cd0dd-78e7-4dd8-a90e-8e2222336810 61 fields · synced Jul 23, 2026
- FDA UDI 1b9f6c38-81d5-4a08-b204-52536bbb588a 32 fields · synced May 30, 2026