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LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex FDA UDI
- Generic Name
- DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching FDA UDI
- Model / Reference
- 628913 FDA UDI
- Description
- DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching FDA UDI
Identifiers
- Catalog Number
- 628913 FDA UDI
- Primary DI / UDI-DI
- 10888234400011 FDA UDI
- FDA Product Code
- MZI FDA UDI
- GMDN Term
- DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) 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: DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)
LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex by Immucor GTI Diagnostics, Inc. — Class U — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as DNA-based tissue typing IVD, kit, nucleic acid technique (NAT).
- LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc. · U
- LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc. · U
- LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc. · U
- LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc. · U
- LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc. · U
- LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc. · U
Cleared under the same submission
BK130075 also covers:
- LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc.
- LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc.
- LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc.
- LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc.
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 4f8cb7a2-32ad-444d-a525-e555bf29a1a6 37 fields · synced Jun 6, 2026