caredx.comAlloMap Heart Molecular Expression Testing
Caredx, Inc.
CareDx, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005225997 | 3005225997 | CareDx, Inc. | 1 | N | 2026-01-01 | 3260 Bayshore Blvd BRISBANE CA US 94005 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860193001709 | AlloSure Specimen Collection Kit - Convenience Kit for Phlebotomy kit of blood sample for AlloSure testing | 415-287-2427 | rramirez@caredx.com |
| 00860193001716 | Allomap Specimen Collection Kit - Convenience Kit for Phlebotomy of blood sample for AlloMap testing | 415-287-2427 | rramirez@caredx.com |
| 00860193001723 | HeartCare Specimen Collection Kit - Convenience Kit for Phlebotomy of blood sample for HeartCare testing | 415-287-2427 | rramirez@caredx.com |
| 00860193001730 | KidneyCare Specimen Collection Kit - Convenience Kit for Specimen Collection Phlebotomy | 415-287-2427 | rramirez@caredx.com |
| 00860193001747 | KidneyCare Specimen Collection Kit - Convenience mobile phlebotomy sample collection kit | 4152872427 | rramirez@caredx.com |
| 00860193001754 | CareDx - Needle, Vacutainer® Safety-Lok™ Blood Collection Set | 4152872427 | rramirez@caredx.com |
| 00860193001761 | UroMap Specimen Collection Kit - The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus nephropathy in kidney transplant patients. The UroMap Specimen collection kit is not intended for home use and is intended to be used by trained medical personnel. | 4152872427 | rramirez@caredx.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 24196 | 1960653247 | K221640 | AlloMap Heart Molecular Expression Testing | OJQ | 2023-09-13 |
| 24196 | 1667782711 | DEN080007 | ALLOMAP MOLECULAR EXPRESSION TESTING | OJQ | 2008-08-26 |
| 24196 | 1758787835 | ||||
| 24196 | 1923081710 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OJQ | 2 | 2023-09-13 |
PMN#
GUDID#
CareDx - Needle, Vacutainer® Safety-Lok™ Blood Collection Set
2023-07-24
UroMap Specimen Collection Kit - The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus nephropathy in kidney transplant patients. The UroMap Specimen collection kit is not intended for home use and is intended to be used by trained medical personnel.
2023-02-10
KidneyCare Specimen Collection Kit - Convenience Kit for Specimen Collection Phlebotomy
2022-10-31
KidneyCare Specimen Collection Kit - Convenience mobile phlebotomy sample collection kit
2022-10-31
AlloSure Specimen Collection Kit - Convenience Kit for Phlebotomy kit of blood sample for AlloSure testing
2020-04-30
Allomap Specimen Collection Kit - Convenience Kit for Phlebotomy of blood sample for AlloMap testing
2020-04-30
HeartCare Specimen Collection Kit - Convenience Kit for Phlebotomy of blood sample for HeartCare testing
2020-04-30