Identity
- Trade Name
- uTYPE™ Dx HLA Sequence Analysis Software FDA UDI
- Generic Name
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- Processes DNA sample data files of Class I and Class II Human Leukocyte Antigens (HLA) for analysis and HLA allele assignment by comparison to the IMGT/HLA database with uTYPE. The sample data files are generated from samples processed with SeCore™ SBT Sequencing kits or GSSP SBT Sequencing kits and the Applied Biosystems Genetic Analyzer. FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Processes DNA sample data files of Class I and Class II Human Leukocyte Antigens (HLA) for analysis and HLA allele assignment by comparison to the IMGT/HLA database with uTYPE. The sample data files are generated from samples processed with SeCore™ SBT Sequencing kits or GSSP SBT Sequencing kits and the Applied Biosystems Genetic Analyzer. FDA UDI
Identifiers
- Catalog Number
- 539993 FDA UDI
- Primary DI / UDI-DI
- 00814695021765 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
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™ Dx HLA Sequence Analysis Software by One Lambda, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
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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 3c1608b1-784d-4159-9dd9-d030e25c263e 35 fields · synced May 30, 2026