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SSP HLA C high

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 101.707-12uModel Olerup SSP

by CareDx AB

Identity

Trade Name
HLA-C high FDA UDI
Generic Name
HLA class I antigen tissue typing IVD, kit, multiplex FDA UDI
Device Name
SSP HLA C high EUDAMED
Model / Reference
Olerup SSP EUDAMED
101.707-12u EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
07340035506386 EUDAMEDFDA UDI
Basic UDI-DI
B-07340035506386 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 General EUDAMED
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

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

No

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

SSP HLA C high by CareDx AB — 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

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Manufacturer

Manufacturer
CareDx AB
EUDAMED SRN
SE-MF-000040995

Sources (2)

  • EUDAMED a6872f9b-12c7-4356-8faf-878aa003f2ce 61 fields · synced Jun 18, 2026
  • FDA UDI 3da48a89-dffd-4eb5-a52b-78c38e907e76 32 fields · synced May 30, 2026