Identity
- Trade Name
- LIFECODES LSA Class II FDA UDI
- Generic Name
- HLA class II antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation. FDA UDI
- Model / Reference
- 265200IVD FDA UDI
- Description
- LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation. FDA UDI
Identifiers
- Catalog Number
- 265200IVD FDA UDI
- Primary DI / UDI-DI
- 10888234400349 FDA UDI
- FDA Product Code
- MZI FDA UDI
- GMDN Term
- HLA class 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: HLA class II antigen tissue typing IVD, kit, multiplex
LIFECODES LSA Class II by Immucor GTI Diagnostics, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HLA class II antigen tissue typing IVD, kit, multiplex.
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
- Immucor GTI Diagnostics, Inc.
Sources (1)
- FDA UDI 8b9b3d9d-6c17-4146-bc47-03bda328e7ae 37 fields · synced May 30, 2026