Identity
- Trade Name
- Dilution Solution FDA UDI
- Generic Name
- DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- For Use with HLA-SSO Typing Kits FDA UDI
- Model / Reference
- 628155 FDA UDI
- Description
- For Use with HLA-SSO Typing Kits FDA UDI
Identifiers
- Catalog Number
- 628155 FDA UDI
- Primary DI / UDI-DI
- 10888234400745 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
- Not 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
No
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
Dilution Solution by Immucor GTI Diagnostics, Inc. — Class U — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
BK130075 also covers:
- LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex — Immucor GTI Diagnostics, Inc.
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Immucor GTI Diagnostics, Inc.
Sources (2)
- FDA UDI 3a1fdc15-dd90-40e5-837e-c33684675af7 38 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026