Identity
- Trade Name
- uTYPE™ CDx HLA Sequence Analysis Software FDA UDI
- Generic Name
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system FDA UDI
- Model / Reference
- UTPCDX-PGR FDA UDI
- Description
- The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system FDA UDI
Identifiers
- Catalog Number
- UTPCDX-PGR FDA UDI
- Primary DI / UDI-DI
- 00812117016849 FDA UDI
- FDA Product Code
- QUK FDA UDI
- GMDN Term
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
uTYPE™ CDx HLA Sequence Analysis Software by One Lambda, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- One Lambda, Inc.
Sources (1)
- FDA UDI 2bf9bbd7-ed65-4fe8-85b8-e70ad02a77e0 35 fields · synced May 30, 2026