FDA UDI
In Commercial Distribution
🇺🇸 United States
CERULOPLASMIN (CPL)
DI: 05055273207071
·
Model: CPL4017
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CERULOPLASMIN (CPL)
- Primary DI
- 05055273207071
- Version / Model
- CPL4017
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-03
- Public Version
- 1
- Public Version Date
- 2019-06-11
- Public Version Status
- New
- Public Device Record Key
- f3aa6cdb-c8dc-419e-8fce-144d1f58785f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | Immunology | 866.5210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53632 | Ceruloplasmin IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of ceruloplasmin in a clinical specimen, using a nephelometry/turbidimetry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273207071 | GS1 |