| Primary Device ID | 00860193001754 |
| NIH Device Record Key | 591adf40-40aa-460a-9734-fe353ac07d7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareDx |
| Version Model Number | RMT-00011 |
| Catalog Number | RMT-00011 |
| Company DUNS | 102819484 |
| Company Name | CAREDX, 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 |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com | |
| Phone | 4152872427 |
| rramirez@caredx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860193001754 [Primary] |
| PXL | Venipuncture Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-01 |
| Device Publish Date | 2023-07-24 |
| 00860193001754 - CareDx | 2023-08-01Needle, Vacutainer® Safety-Lok™ Blood Collection Set |
| 00860193001754 - CareDx | 2023-08-01 Needle, Vacutainer® Safety-Lok™ Blood Collection Set |
| 00860193001761 - UroMap Specimen Collection Kit | 2023-02-20 The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the pr |
| 00860193001730 - KidneyCare Specimen Collection Kit | 2022-11-08 Convenience Kit for Specimen Collection Phlebotomy |
| 00860193001747 - KidneyCare Specimen Collection Kit | 2022-11-08 Convenience mobile phlebotomy sample collection kit |
| 00860193001709 - AlloSure Specimen Collection Kit | 2020-05-08 Convenience Kit for Phlebotomy kit of blood sample for AlloSure testing |
| 00860193001716 - Allomap Specimen Collection Kit | 2020-05-08 Convenience Kit for Phlebotomy of blood sample for AlloMap testing |
| 00860193001723 - HeartCare Specimen Collection Kit | 2020-05-08 Convenience Kit for Phlebotomy of blood sample for HeartCare testing |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CAREDX 90618017 not registered Live/Pending |
CareDx, Inc. 2021-04-01 |
![]() CAREDX 86975205 not registered Dead/Abandoned |
CAREDX, INC. 2014-03-13 |
![]() CAREDX 86605293 4884670 Live/Registered |
CareDx, Inc. 2015-04-21 |
![]() CAREDX 86220870 5064628 Live/Registered |
CAREDX, INC. 2014-03-13 |
![]() CAREDX 77958561 3896426 Live/Registered |
CAREDX, INC. 2010-03-14 |