FDA UDI
In Commercial Distribution
🇺🇸 United States
Gamma N-HANCE
DI: 10888234001805
·
Model: 0705403
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gamma N-HANCE
- Primary DI
- 10888234001805
- Version / Model
- 0705403
- Catalog Number
- 0705403
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-15
- Public Version
- 5
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- b3cb6093-a3f6-477d-9450-1a964d84834f
Device 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 three (3) vial configuration.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSG | Media, Potentiating For In Vitro Diagnostic Use | Hematology | 864.9600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52718 | Low ionic-strength salt solution (LISS) immunohaematology reagent IVD | A substance or reactant known as low ionic-strength salt solution (LISS), or low ionic strength saline, intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions. It is a solution typically consisting of a sodium salt, glycine and low-salt albumin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234001805 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK860024 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius