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Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin FDA UDI
- Generic Name
- Anti-A1 red blood cell grouping IVD, lectin FDA UDI
- Device Name
- Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiate A1 red blood cells from those of other A subgroups in saline slide or tube tests. This is a lectin product. This product is in a single vial configuration. FDA UDI
- Model / Reference
- 0012280 FDA UDI
- Description
- Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiate A1 red blood cells from those of other A subgroups in saline slide or tube tests. This is a lectin product. This product is in a single vial configuration. FDA UDI
Identifiers
- Catalog Number
- 0012280 FDA UDI
- Primary DI / UDI-DI
- 10888234000952 FDA UDI
- FDA Product Code
- KSI FDA UDI
- GMDN Term
- Anti-A1 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-A1 red blood cell grouping IVD, lectin
Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-A1 red blood cell grouping IVD, lectin.
- ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin — ALBA BIOSCIENCE LIMITED · Class II
- ORTHO — Ortho-Clinical Diagnostics · Class II
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 86022986-3483-4e52-a20d-e5147eee4e79 37 fields · synced May 30, 2026