| Primary Device ID | 00860009877931 |
| NIH Device Record Key | f7aea458-95c9-49fb-ada3-03264cdde594 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | kidneyintelX.dkd Single Tube Specimen Collection KIt |
| Version Model Number | RENX-3011087 |
| Company DUNS | 117063935 |
| Company Name | Renalytix Ai, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009877931 [Primary] |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-24 |
| Device Publish Date | 2024-04-16 |
| 00860009877924 - kidneyintelX.dkd Test | 2024-10-08 Test Report for the kidneyintelX.dkd test. |
| 00860009877931 - kidneyintelX.dkd Single Tube Specimen Collection KIt | 2024-04-24Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing |
| 00860009877931 - kidneyintelX.dkd Single Tube Specimen Collection KIt | 2024-04-24 Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintel |
| 00860009877900 - KidneyIntelX Blood Collection Convenience Kit | 2024-04-09 Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX tes |
| 00860009877917 - RenalytixAI Urine Collection Kit | 2024-04-09 Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing |
| 00196852040506 - KidneyIntelX Blood Collection Convenience Kit | 2023-02-28 Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX tes |
| 00196852375677 - RenalytixAI Urine Collection Kit | 2023-02-28 Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing |
| G229RENX30110031 - RenalytixAI Urine Collection Kit | 2022-05-16 Collection kit for urine specimen |
| G229RENX30110001 - KidneyIntelX Blood Collection Convenience Kit | 2022-05-11 Whole blood collection convenience kit for KidneyIntelX |