FDA UDI
In Commercial Distribution
🇺🇸 United States
GSP Neonatal Creatine Kinase -MM kit
DI: 06438147362615
·
Model: 3311-001U
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GSP Neonatal Creatine Kinase -MM kit
- Primary DI
- 06438147362615
- Version / Model
- 3311-001U
- Catalog Number
- 3311-001U
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-04
- Public Version
- 2
- Public Version Date
- 2022-02-15
- Public Version Status
- Update
- Public Device Record Key
- ee98419d-ba50-479d-a94d-429b879db213
Device Description
For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood. Note: Kit contains multiple packages.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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 |
|---|---|---|---|---|
| QJE | Muscular Dystrophy Newborn Screening Test | Clinical Chemistry | 862.1506 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61787 | Creatine kinase skeletal muscle isoenzyme (CKMM) IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase skeletal muscle isoenzyme (CKMM) in a clinical specimen, using a fluorescent immunoassay method. It is typically used to assess the extent of muscle damage in and to screen for muscular dystrophy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438147362615 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -16 Degrees Celsius