FDA UDI
In Commercial Distribution
🇺🇸 United States
HYPERGAMMA CONTROL (5)
DI: 03607360047873
·
Model: 4787
·
SEBIA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYPERGAMMA CONTROL (5)
- Primary DI
- 03607360047873
- Version / Model
- 4787
- Catalog Number
- 4787
- Company Name
- SEBIA
- Labeler DUNS
- 276801933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-12
- Public Version
- 1
- Public Version Date
- 2022-12-20
- Public Version Status
- New
- Public Device Record Key
- 40c7f7c7-fe4f-429a-9c08-87470877d027
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
- Yes
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53969 | Protein electrophoresis IVD, control | A material which is used to verify the performance of an assay intended to be used for determining the qualitative and/or quantitative separation of proteins by electrophoresis, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607360047873 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius