Identity
- Trade Name
- Anti-H (Ulex europaeus) FDA UDI
- Generic Name
- Anti-H red blood cell grouping IVD, lectin FDA UDI
- Device Name
- Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration. FDA UDI
- Model / Reference
- 0007151 FDA UDI
- Description
- Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration. FDA UDI
Identifiers
- Catalog Number
- 0007151 FDA UDI
- Primary DI / UDI-DI
- 10888234000723 FDA UDI
- FDA Product Code
- KSI FDA UDI
- GMDN Term
- Anti-H red blood cell grouping IVD, lectin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9550 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
Yes
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: Anti-H red blood cell grouping IVD, lectin
Anti-H (Ulex europaeus) by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI 58c1b6dd-a003-4496-9560-981ae43adaa2 36 fields · synced May 31, 2026