Identity
- Trade Name
- Conjugate Concentrate FDA UDI
- Generic Name
- HLA class I & II antigen tissue typing IVD, reagent FDA UDI
- Device Name
- For Use with LIFECODES Class I ID and LIFECODES Class II IDv2 FDA UDI
- Model / Reference
- 628201 FDA UDI
- Description
- For Use with LIFECODES Class I ID and LIFECODES Class II IDv2 FDA UDI
Identifiers
- Catalog Number
- 628201 FDA UDI
- Primary DI / UDI-DI
- 10888234400561 FDA UDI
- FDA Product Code
- MZI FDA UDI
- GMDN Term
- HLA class I & II antigen tissue typing IVD, reagent 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
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
Category: HLA class I & II antigen tissue typing IVD, reagent
Conjugate Concentrate 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, reagent.
Cleared under the same submission
BK040035 also covers:
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 b8cbaf7b-1eb3-4258-b625-f9d0ecb87d48 37 fields · synced May 30, 2026