FDA UDI
In Commercial Distribution
🇺🇸 United States
NEPHROCHECK Test Kit
DI: B0745000110
·
Model: 500011
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NEPHROCHECK Test Kit
- Primary DI
- B0745000110
- Version / Model
- 500011
- Catalog Number
- 500011
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 3
- Public Version Date
- 2023-02-01
- Public Version Status
- Update
- Public Device Record Key
- cb10307f-d024-484c-b1bb-76d22049461f
Device Description
The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.
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 |
|---|---|---|---|---|
| 60639 | Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials 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, using a fluorescent immunoassay method. 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 | B0745000110 | HIBCC |