FDA UDI
In Commercial Distribution
🇺🇸 United States
LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)
DI: 05055273204445
·
Model: LP3406
·
RANDOX LABORATORIES LIMITED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)
- Primary DI
- 05055273204445
- Version / Model
- LP3406
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-05
- Public Version
- 1
- Public Version Date
- 2022-10-13
- Public Version Status
- New
- Public Device Record Key
- 7c95a6b8-07b6-408b-aed9-1b406fccfe48
Device Description
Randox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a).
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JIS | Calibrator, Primary | Clinical Chemistry | 862.1150 | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | Immunology | 866.5600 | 2 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41418 | Lipoprotein A IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273204445 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius