Identity
- Trade Name
- NEPHROCHECK Liquid Control Kit FDA UDI
- Generic Name
- Multiple acute kidney injury (AKI) marker IVD, control FDA UDI
- Device Name
- The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System. FDA UDI
- Model / Reference
- 500013 FDA UDI
- Description
- The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System. FDA UDI
Identifiers
- Catalog Number
- 500013 FDA UDI
- Primary DI / UDI-DI
- B0745000130 FDA UDI
- FDA Product Code
- PIG FDA UDI
- GMDN Term
- Multiple acute kidney injury (AKI) marker IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple acute kidney injury (AKI) marker IVD, control
NEPHROCHECK Liquid Control Kit by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple acute kidney injury (AKI) marker IVD, control.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI ea94055e-5677-44a3-a7b7-7e7a7206516f 34 fields · synced May 30, 2026