FDA UDI
In Commercial Distribution
🇺🇸 United States
VIDAS® NEPHROCHECK®
DI: 03573026616038
·
Model: 421172-01
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VIDAS® NEPHROCHECK®
- Primary DI
- 03573026616038
- Version / Model
- 421172-01
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-13
- Public Version
- 1
- Public Version Date
- 2023-03-21
- Public Version Status
- New
- Public Device Record Key
- 8cdf19ab-9e83-49ca-8e26-cd69f9ae799c
Device Description
VIDAS NEPHROCHECK 60 TESTS is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the risk assessment for moderate or severe acute kidney injury
Device Characteristics
- Single Use
- No
- 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 | 03573026616038 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210793 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius