FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NEPHROCHECK Calibration Verification (Cal Vers) Kit
DI: B0745000090
·
Model: 500009
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NEPHROCHECK Calibration Verification (Cal Vers) Kit
- Primary DI
- B0745000090
- Version / Model
- 500009
- Catalog Number
- 500009
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 4
- Public Version Date
- 2026-01-23
- Public Version Status
- Update
- Public Device Record Key
- 83bacfbf-2f91-475e-9dbc-f57df5fc8042
- Distribution End Date
- 2023-12-12
Device Description
The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.
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
- 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 |
|---|---|---|---|---|
| PIG | Acute Kidney Injury Test System | Clinical Chemistry | 862.1220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60651 | Multiple acute kidney injury (AKI) marker IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple antigens or markers associated with acute kidney injury (AKI) in a clinical specimen. The range of analytes detected may include (but is not limited to) insulin-like growth factor-binding protein 7 (IGFBP-7), neutrophil gelatinase-associated lipocalin (NGAL), tissue-inhibitor of metalloproteinase-2 (TIMP-2), cystatin C, kidney injury molecule-1 (Kim-1) and/or L-type fatty acid–binding protein (L-FABP). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B0745000090 | HIBCC |