Identity
- Trade Name
- LISS FDA UDI
- Generic Name
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
- Device Name
- Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohematological testing in tube methods FDA UDI
- Model / Reference
- 210544 FDA UDI
- Description
- Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohematological testing in tube methods FDA UDI
Identifiers
- Catalog Number
- 210544 FDA UDI
- Primary DI / UDI-DI
- 23661562105445 FDA UDI
- FDA Product Code
- KSG FDA UDI
- GMDN Term
- Low ionic-strength salt solution (LISS) 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
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Liss by Diagast — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Low ionic-strength salt solution (LISS) immunohaematology reagent IVD.
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- Capture LISS — IMMUCOR, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagast
Sources (2)
- FDA UDI 4a27a21d-d056-4cc9-a515-013211ed3994 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 4, 2026