SeCore™ B Locus Sequencing Kit, Single Amplification System
FDA UDIEUDAMEDClass U (US FDA UDI)
Identity
- Trade Name
- SeCore™ B Locus Sequencing Kit, Single Amplification EUDAMEDSeCore™ B Locus Sequencing Kit, Single Amplification System FDA UDI
- Generic Name
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA). FDA UDI
- Model / Reference
- SeCore™ HLA Sequencing System EUDAMED5311025D EUDAMEDN/A FDA UDI
- Description
- SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA). FDA UDI
Identifiers
- Catalog Number
- 5311025D FDA UDI
- Primary DI / UDI-DI
- 00814695022854 EUDAMEDFDA UDI
- Basic UDI-DI
- 081469502SECGZ EUDAMED
- Direct Marketing DI
- 00814695022854 EUDAMED
- FDA Product Code
- MZI FDA UDI
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
- GMDN Term
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class C EUDAMEDU FDA UDI
- Market of Registration
- Germany 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
New Device
No
Prescription Use
Yes
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
SeCore™ B Locus Sequencing Kit, Single Amplification System by One Lambda, Inc. — Class U — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
- SSP DRB1*13 — CareDx AB · IVD Annex II List B
- SSP HLA-A*25 — CareDx AB · IVD Annex II List B
- SSP HLA-B*67 — CareDx AB · IVD Annex II List B
- SSP HLA-B*41 — CareDx AB · IVD Annex II List B
- SSP HLA-B*73 — CareDx AB · IVD Annex II List B
- AlloSeq Tx 9 — CareDx Pty Ltd · IVD Annex II List B
- SSP DRB4*01:03:01:02N — CareDx AB · IVD Annex II List B
- SSP HLA-A*80 — CareDx AB · IVD Annex II List B
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- One Lambda, Inc.
Sources (2)
- FDA UDI cfd2d1c6-a7de-4cc9-b686-eb71d8083c32 36 fields · synced Jul 25, 2026
- EUDAMED ec068eab-8484-489f-9333-371b215c7913 61 fields · synced Jul 25, 2026