Gamma-Quin
- Primary DI
- 10888234000891
- Brand
- Gamma-Quin
- Company
- IMMUCOR, INC.
- Model
- 0007890
- Catalog number
- 0007890
- Device description
- Gamma-Quin is intended for use in removing red cell-bound immunoglobulin. Gamma-Quin is an approximately 16% solution of chloroquine diphosphate in phosphate-buffered saline at a pH of about 5.0. This package configuration is one (1) vial of 10 mL volume.
- Published
- 2016-04-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
immucor.comProduct Codes#
| Code | Name |
|---|---|
| KSK | Solution, Stabilized Enzyme |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| KSK | Solution, Stabilized Enzyme | Hematology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K813342 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10888234000891 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10888234000891 | 10888234000891 |
GMDN Terms#
| Term | Definition |
|---|---|
| Immunoglobulin removal reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 1 Degrees Celsius | 10 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 1-855-466-8267 | tech_support@immucor.com |
Regulatory Flags#
- DUNS number
- 061446282
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- Contains natural rubber latex
- true
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