Identity
- Trade Name
- SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit 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
- N/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
- A15573 FDA UDI
- Primary DI / UDI-DI
- 00812117017563 FDA UDI
- FDA Product Code
- MZI FDA UDI
- GMDN Term
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit by One Lambda, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- One Lambda, Inc.
Sources (1)
- FDA UDI 98985323-19e6-41fe-9da0-ad35cf079c15 36 fields · synced May 31, 2026