Identity
- Trade Name
- Kidney KFRE Algorithm FDA UDI
- Generic Name
- Clinical management support software IVD FDA UDI
- Model / Reference
- 09891986001 FDA UDI
Identifiers
- Catalog Number
- 09891986001 FDA UDI
- Primary DI / UDI-DI
- 07613336223321 FDA UDI
- FDA Product Code
- JQP FDA UDI
- GMDN Term
- Clinical management support software IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Clinical management support software IVD
Kidney KFRE Algorithm by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clinical management support software IVD.
- Neon — MetaSystems Hard & Software GmbH · Class I
- HERA — Aesku.Diagnostics GmbH & Co. KG · Class I
- Sepsis ImmunoScore — Prenosis, Inc. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI df8b31a1-b0db-49ca-94f7-1b99916b8692 33 fields · synced May 30, 2026