Identity
- Trade Name
- LIFECODES LifeScreen XP FDA UDI
- Generic Name
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation. FDA UDI
- Model / Reference
- 628220 FDA UDI
- Description
- LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation. FDA UDI
Identifiers
- Catalog Number
- 628220 FDA UDI
- Primary DI / UDI-DI
- 10888234500841 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
LIFECODES LifeScreen XP by Immucor GTI Diagnostics, 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.
- LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit — ONE LAMBDA, INC. · Class C
- LABType™ HD Class I B Locus Typing Test - 20 tests — ONE LAMBDA, INC. · U
- SSP DRB1*13 — CareDx AB · IVD Annex II List B
- SSP HLA-A*25 — CareDx AB · IVD Annex II List B
- HLA Class I Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody — ONE LAMBDA, INC. · U
- SSP HLA-B*67 — CareDx AB · IVD Annex II List B
- Micro SSP™ AmbiStrips™ HLA Class I - A0101N — ONE LAMBDA, INC. · U
- SSP HLA-B*41 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immucor GTI Diagnostics, Inc.
Sources (1)
- FDA UDI 5c22c2e0-70a6-4ab5-9f48-702ff7ef21f0 37 fields · synced May 30, 2026