Identity
- Trade Name
- Gamma LO-ION FDA UDI
- Generic Name
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
- Device Name
- Gamma LO-ION is intended as an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration. FDA UDI
- Model / Reference
- 0704610 FDA UDI
- Description
- Gamma LO-ION is intended as an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration. FDA UDI
Identifiers
- Catalog Number
- 0704610 FDA UDI
- Primary DI / UDI-DI
- 10888234001775 FDA UDI
- 510(k) Number
- K790973 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
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: Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Gamma LO-ION by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Low ionic-strength salt solution (LISS) immunohaematology reagent IVD.
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- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- LISS — DIAGAST · 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 9420f8f8-c276-42d7-abf2-2df4fed98c1b 37 fields · synced Jun 1, 2026