FDA UDI
In Commercial Distribution
🇺🇸 United States
BNP CONTROLS FOR BECKMAN (BNP CONTROL)
DI: 05055273218480
·
Model: CQ10520
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BNP CONTROLS FOR BECKMAN (BNP CONTROL)
- Primary DI
- 05055273218480
- Version / Model
- CQ10520
- Catalog Number
- CQ10520
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-21
- Public Version
- 1
- Public Version Date
- 2023-12-29
- Public Version Status
- New
- Public Device Record Key
- 8d8820c2-667f-4c77-923e-3e4aa57c1cf1
Device Description
The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination of BNP in human serum and plasma. The BNP Controls for Beckman (CQ10520) are assayed with target values and are suitable for use on Beckman analysers. The BNP Controls for Beckman (CQ10520) are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47354 | B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273218480 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius