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kidneyintelX.dkd Single Tube Specimen Collection KIt
FDA UDIClass II (US FDA UDI)
by Renalytixai
Identity
- Trade Name
- kidneyintelX.dkd Single Tube Specimen Collection KIt FDA UDI
- Generic Name
- General specimen collection kit FDA UDI
- Device Name
- Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing FDA UDI
- Model / Reference
- RENX-3011087 FDA UDI
- Description
- Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009877931 FDA UDI
- FDA Product Code
- PQD FDA UDI
- GMDN Term
- General specimen collection kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen collection kit
kidneyintelX.dkd Single Tube Specimen Collection KIt by Renalytixai — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Renalytixai
Sources (1)
- FDA UDI f7aea458-95c9-49fb-ada3-03264cdde594 33 fields · synced May 30, 2026