Identity
- Trade Name
- Gamma N-HANCE FDA UDI
- Generic Name
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
- Device Name
- Gamma N-HANCE is used 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
- 0705410 FDA UDI
- Description
- Gamma N-HANCE is used 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
- 0705410 FDA UDI
- Primary DI / UDI-DI
- 10888234001812 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 N-HANCE by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Low ionic-strength salt solution (LISS) immunohaematology reagent IVD.
- IH-LISS Rack — Bio-Rad Medical Diagnostics GmbH · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- ALBAhance LISS Additive Reagent — ALBA BIOSCIENCE LIMITED · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- MLB 2 — Bio-Rad Medical Diagnostics GmbH · Class II
- LISS — DIAGAST · Class II
- ORTHO — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
BK860024 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 94b866cd-bda5-47ad-9d81-2a0a2b0fae7c 37 fields · synced Jun 1, 2026