Identity
- Trade Name
- Specimen Diluent FDA UDI
- Generic Name
- Cell preservation/storage/dilution solution IVD FDA UDI
- Device Name
- Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume. FDA UDI
- Model / Reference
- 0066052 FDA UDI
- Description
- Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume. FDA UDI
Identifiers
- Catalog Number
- 0066052 FDA UDI
- Primary DI / UDI-DI
- 10888234001065 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Cell preservation/storage/dilution solution IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 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: Cell preservation/storage/dilution solution IVD
Specimen Diluent by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK070016 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 II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI 674426a2-3468-449a-9fb7-79bcdd3b7b96 37 fields · synced Jun 8, 2026