Accelerate Diagnostics Inc

FDA Filings

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

USA

NASDAQ

AXDX

DUNS 186328670

FDA Registration(s)

• Registration Number: 3010671651
• FEI Number: 3010671651
• Name: ACCELERATE DIAGNOSTICS, INC.
• Owner & Operator: Accelerate Diagnostics Inc.,
• Contact Address: 3950 S. Country Club Road Suite 470 ; Tucson AZ 85714 US
• Official Correspondent:
  • Carrene Plummer
  • 1-520-4051462-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3950 S COUNTRY CLUB RD STE 470 ; Tucson, AZ 85714 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00862011000383 ACCELERATE DIAGNOSTICS, INC.	Accelerate PhenoTest BC kit	2021-11-12
GUDID 10862011000342 ACCELERATE DIAGNOSTICS, INC.	Accelerate PhenoTest BC AST QC test	2020-12-21
GUDID 10862011000335 ACCELERATE DIAGNOSTICS, INC.	Accelerate PhenoTest BC ID QC test	2020-12-21
PMN K192665 Accelerate Diagnostics, Inc.	Accelerate Pheno System, Accelerate PhenoTest BC Kit	2020-09-15
GUDID 00862011000369 ACCELERATE DIAGNOSTICS, INC.	Accelerate PhenoTest® BC kit	2020-07-23
GUDID 00862011000352 ACCELERATE DIAGNOSTICS, INC.	Accelerate PhenoTest® BC AST QC test	2020-07-23
GUDID 00862011000321 ACCELERATE DIAGNOSTICS, INC.	Accelerate Pheno™ System	2019-08-20
GUDID 00862011000314 ACCELERATE DIAGNOSTICS, INC.	Accelerate Pheno™ System	2019-08-20
GUDID 00862011000307 ACCELERATE DIAGNOSTICS, INC.	Accelerate PhenoTest™ BC Kit	2019-08-20
PMN DEN160032 | PRH ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC kit	2017-03-02
PMN DEN160032 | PRH ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC ID QC test	2017-03-02
PMN DEN160032 | PRH ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC AST QC test	2017-03-02
PMN DEN160032 | PRH ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate Pheno system	2017-03-02
PMN DEN160032 | PEO ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC kit	2017-03-02
PMN DEN160032 | PEO ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC ID QC test	2017-03-02
PMN DEN160032 | PEO ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC AST QC test	2017-03-02
PMN DEN160032 | PEO ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate Pheno system	2017-03-02
PMN DEN160032 | PEN ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC kit	2017-03-02
PMN DEN160032 | PEN ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC ID QC test	2017-03-02
PMN DEN160032 | PEN ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC AST QC test	2017-03-02
PMN DEN160032 | PEN ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate Pheno system	2017-03-02
PMN DEN160032 | PAM ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC kit	2017-03-02
PMN DEN160032 | PAM ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC ID QC test	2017-03-02
PMN DEN160032 | PAM ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC AST QC test	2017-03-02
PMN DEN160032 | PAM ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate Pheno system	2017-03-02
PMN DEN160032 | NSU ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC kit	2017-03-02
PMN DEN160032 | NSU ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC ID QC test	2017-03-02
PMN DEN160032 | NSU ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC AST QC test	2017-03-02
PMN DEN160032 | NSU ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate Pheno system	2017-03-02
PMN DEN160032 | LON ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC kit	2017-03-02
PMN DEN160032 | LON ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC ID QC test	2017-03-02
PMN DEN160032 | LON ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate PhenoTest BC AST QC test	2017-03-02
PMN DEN160032 | LON ACCELERATE DIAGNOSTICS, INC. [Accelerate Diagnostics Inc.,]	Accelerate Pheno system	2017-03-02

Related Finance Registrations

NCAGE Code	0T3P1	ACCELERATE DIAGNOSTICS, INC.
CAGE Code	0T3P1	ACCELERATE DIAGNOSTICS, INC.
S.A.M. Registration	0T3P1 [186328670]	ACCELERATE DIAGNOSTICS, INC.
SEC	0000727207	Accelerate Diagnostics, Inc of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019091239254	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS CODE: 90278099	1 PKG
2018051545699	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES HS CODE: 98130005	2 PKG