Caredx Ab

FDA Filings

This page includes the latest FDA filings for Caredx Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3002522915
• FEI Number: 3002522915
• Name: CAREDX AB
• Owner & Operator: CareDx AB
• Contact Address: Franzengatan 5 ; Stockholm SE-AB Stockholms lan [SE-01] 11251 SE
• Official Correspondent:
  • Maria Ilar
  • 046-70-8840355-x
• US Agent:
  • Wilk von Gustedt
  • CareDx Inc.
  • 415 2872312
  • wgustedt@caredx.com
• Importing Logistics Registration:
  • Importer: Olerup, Inc.
  • Address: 901 S Bolmar St Suite R ; West Chester, PA 19382 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Franzengatan 5 ; STOCKHOLM Stockholms lan [SE-01], SE-112 51 SE
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 07340035504368 CareDx AB	HLA-B*38	2023-07-26
GUDID 07340035504344 CareDx AB	SSP HLA-B*15	2023-07-26
GUDID 07340035504320 CareDx AB	SSP HLA-B*15	2023-07-26
GUDID 07340035504306 CareDx AB	SSP HLA-B*14	2023-07-26
GUDID 07340035504283 CareDx AB	SPP HLA-B*13	2023-07-26
GUDID 07340035504269 CareDx AB	HLA-B*45	2023-07-26
GUDID 07340035504245 CareDx AB	HLA-B*44	2023-07-26
GUDID 07340035504221 CareDx AB	HLA-B*44	2023-07-26
GUDID 07340035504207 CareDx AB	SSP HLA-B*08	2023-07-26
GUDID 07340035504184 CareDx AB	SSP HLA-B*08	2023-07-26
GUDID 07340035504160 CareDx AB	SSP HLA-B*07	2023-07-26
GUDID 07340035504146 CareDx AB	SSP HLA-B*07	2023-07-26
GUDID 07340035504122 CareDx AB	HLA-B*52	2023-07-26
GUDID 07340035504108 CareDx AB	HLA-B*51	2023-07-26
GUDID 07340035504085 CareDx AB	HLA-B*51	2023-07-26
GUDID 07340035504047 CareDx AB	SSP HLA-B low	2023-07-26
GUDID 07340035504023 CareDx AB	SSP HLA-B low	2023-07-26
GUDID 07340035503705 CareDx AB	SSP HLA-A*69	2023-07-26
GUDID 07340035503682 CareDx AB	SSP HLA-A low Screening	2023-07-26
GUDID 07340035503668 CareDx AB	SSP HLA-A Low Screening	2023-07-26
GUDID 07340035503606 CareDx AB	SSP HLA-A*80	2023-07-26
GUDID 07340035503583 CareDx AB	SSP HLA-A*2409N	2023-07-26
GUDID 07340035503545 CareDx AB	SSP HLA-A*68	2023-07-26
GUDID 07340035503521 CareDx AB	SSP HLA-A*68	2023-07-26
GUDID 07340035503507 CareDx AB	SSP HLA-A*36	2023-07-26
GUDID 07340035503484 CareDx AB	SSP HLA-A*74	2023-07-26
GUDID 07340035503460 CareDx AB	SSP HLA-A*33	2023-07-26
GUDID 07340035503446 CareDx AB	SSP HLA-A*32	2023-07-26
GUDID 07340035503422 CareDx AB	SSP HLA-A*31	2023-07-26
GUDID 07340035503408 CareDx AB	SSP HLA-A*30	2023-07-26
GUDID 07340035503385 CareDx AB	SSP HLA-A*29	2023-07-26
GUDID 07340035503361 CareDx AB	SSP HLA-A*11	2023-07-26
GUDID 07340035503347 CareDx AB	SSP HLA-A*11	2023-07-26
GUDID 07340035503323 CareDx AB	SSP HLA-A*66	2023-07-26
GUDID 07340035503309 CareDx AB	SSP HLA-A*34	2023-07-26
GUDID 07340035503286 CareDx AB	SSP HLA-A*26	2023-07-26
GUDID 07340035503262 CareDx AB	SSP HLA-A*25	2023-07-26
GUDID 07340035503248 CareDx AB	SSP HLA-A*24	2023-07-26
GUDID 07340035503224 CareDx AB	SSP HLA-A*24	2023-07-26
GUDID 07340035503200 CareDx AB	SSP HLA-A*23	2023-07-26
GUDID 07340035503187 CareDx AB	SSP HLA-A*03	2023-07-26
GUDID 07340035503163 CareDx AB	SSP HLA-A*03	2023-07-26
GUDID 07340035503149 CareDx AB	SSP HLA-A*02	2023-07-26
GUDID 07340035503125 CareDx AB	SSP HLA-A*02	2023-07-26
GUDID 07340035503101 CareDx AB	SSP HLA-A*01	2023-07-26
GUDID 07340035503088 CareDx AB	SSP HLA-A*01	2023-07-26
GUDID 07340035503040 CareDx AB	SSP HLA-A low	2023-07-26
GUDID 07340035503026 CareDx AB	SSP HLA-A low	2023-07-26
GUDID 07340035502081 CareDx AB	SSP DPA1	2023-07-26
GUDID 07340035502067 CareDx AB	SSP DPA1	2023-07-26
GUDID 07340035502043 CareDx AB	SSP DPB1	2023-07-26
GUDID 07340035502029 CareDx AB	SSP DPB1	2023-07-26
GUDID 07340035501367 CareDx AB	DQA1*02,05; DQA1*02,0302	2023-07-26
GUDID 07340035501282 CareDx AB	DQB1*06,02;DQA1*01,02	2023-07-26
GUDID 07340035501268 CareDx AB	SSP DQA1	2023-07-26
GUDID 07340035501244 CareDx AB	SSP DQA1	2023-07-26
GUDID 07340035501220 CareDx AB	SSP DQB1 high	2023-07-26
GUDID 07340035501206 CareDx AB	SSP DQB1*04	2023-07-26
GUDID 07340035501183 CareDx AB	SSP DQB1*03	2023-07-26
GUDID 07340035501169 CareDx AB	SSP DQB1*03	2023-07-26
GUDID 07340035501145 CareDx AB	SSP DQB1*02	2023-07-26
GUDID 07340035501121 CareDx AB	SSP DQB1*06	2023-07-26
GUDID 07340035501107 CareDx AB	SSP DQB1*06	2023-07-26
GUDID 07340035501084 CareDx AB	SSP DQB1*05	2023-07-26
GUDID 07340035501046 CareDx AB	SSP DQ low	2023-07-26
GUDID 07340035501022 CareDx AB	SSP DQ Low	2023-07-26
GUDID 07340035500773 CareDx AB	SSP DR Low Screening	2023-07-26
GUDID 07340035500759 CareDx AB	SSP DR Low Screening	2023-07-26
GUDID 07340035500704 CareDx AB	DRB1*14:01/14:54	2023-07-26
GUDID 07340035500681 CareDx AB	DRB5*01:08N	2023-07-26
GUDID 07340035500667 CareDx AB	DRB4*01:03:01:02N	2023-07-26
GUDID 07340035500605 CareDx AB	SSP DRB5	2023-07-26
GUDID 07340035500582 CareDx AB	SSP DRB5	2023-07-26
GUDID 07340035500568 CareDx AB	SSP DRB4	2023-07-26
GUDID 07340035500544 CareDx AB	SSP DRB4	2023-07-26
GUDID 07340035500520 CareDx AB	SSP DRB3	2023-07-26
GUDID 07340035500506 CareDx AB	SSP DRB3	2023-07-26
GUDID 07340035500483 CareDx AB	SSP DRB1*10	2023-07-26
GUDID 07340035500469 CareDx AB	SSP DRB1*09	2023-07-26
GUDID 07340035500445 CareDx AB	SSP DRB1*12	2023-07-26
GUDID 07340035500421 CareDx AB	SSP DRB1*08	2023-07-26
GUDID 07340035500407 CareDx AB	SSP DRB1*08	2023-07-26
GUDID 07340035500384 CareDx AB	SSP DRB1*07	2023-07-26
GUDID 07340035500360 CareDx AB	SSP DRB1*14	2023-07-26
GUDID 07340035500346 CareDx AB	SSP DRB1*14	2023-07-26
GUDID 07340035500322 CareDx AB	SSP DRB1*13	2023-07-26
GUDID 07340035500308 CareDx AB	SSP DRB1*13	2023-07-26
GUDID 07340035500285 CareDx AB	SSP DRB1*11	2023-07-26
GUDID 07340035500261 CareDx AB	SSP DRB1*11	2023-07-26
GUDID 07340035500247 CareDx AB	SSP DRB1*04	2023-07-26
GUDID 07340035500223 CareDx AB	SSP DRB1*04	2023-07-26
GUDID 07340035500209 CareDx AB	SSP DRB1*03	2023-07-26
GUDID 07340035500186 CareDx AB	SSP DRB1*03	2023-07-26
GUDID 07340035500162 CareDx AB	SSP DRB1*16	2023-07-26
GUDID 07340035500148 CareDx AB	SSP DRB1*15	2023-07-26
GUDID 07340035500124 CareDx AB	SSP DRB1*15	2023-07-26
GUDID 07340035500100 CareDx AB	SSP DRB1*01	2023-07-26
GUDID 07340035500087 CareDx AB	SSP DRB1*01	2023-07-26
GUDID 07340035500049 CareDx AB	SSP DR Low	2023-07-26
GUDID 07340035500025 CareDx AB	SSP DR Low	2023-07-26
PMN BK090042 | MZI CAREDX AB	Olerup SSP? HLA typing kits	2012-08-20
PMN BK080022 | MZI CAREDX AB	Olerup SSP? HLA typing kits	2009-05-13

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