Identity
- Trade Name
- ImmuAdd FDA UDI
- Generic Name
- Bovine serum albumin (BSA) immunohaematology reagent IVD FDA UDI
- Device Name
- ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration. FDA UDI
- Model / Reference
- 0002008 FDA UDI
- Description
- ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration. FDA UDI
Identifiers
- Catalog Number
- 0002008 FDA UDI
- Primary DI / UDI-DI
- 10888234000167 FDA UDI
- FDA Product Code
- KSG FDA UDI
- GMDN Term
- Bovine serum albumin (BSA) immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9600 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: Bovine serum albumin (BSA) immunohaematology reagent IVD
ImmuAdd by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 23db5905-2bda-4dbd-8796-3ccee78b7e89 37 fields · synced May 30, 2026