Bioneer Inc

FDA Filings

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

Bioneer Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

BIONEER CORPORATION

FDA Registration(s)

Registration Number

3010049938

FEI Number

3010049938

Name

BIONEER CORPORATION

Owner & Operator

Bioneer Inc.

Contact Address

155 Filbert St. Suite 216
Oakland CA 94607 US

Official Correspondent

Myeong H Kim
1-877-2644300-x

US Agent

Edgar Elenes
BIONEER, INC.
877 2644300
510 8650350
edgar.elenes@bioneer.us.com

Importing Logistics Registration

Importer	Bioneer Corporation
Address	8-11, Munpyeongseo-ro Daedeok-gu, 306-220 KOREA, REPUBLIC OF
Importer Type	Manufacturer
Subdivision	KR-30

Importing Logistics Registration

Importer	BIONEER, INC.
	146242396
Address	1000 ATLANTIC AVE STE 102 Alameda, CA 94501 UNITED STATES
Email Address	mhkim@bioneer.us.com
Phone	1 510 8650330
FAX	1 510 8650350
Importer Type	RETAILER

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

8-11, Munpyeongseo-ro
Daedeok-gu Daejeon Gwangyeogsi, 34302 KR

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Viral RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Viral DNA/RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Viral DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Mycobacteria genomic DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Blood Genomic DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Bacteria Genomic DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 96 Viral DNA/RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 48 Viral RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 48 Viral DNA/RNA Kit	2017-08-23
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep48 Dx	2010-12-06
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 96 Lite	2010-12-06
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 16 Plus	2010-12-06
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 16 Dx	2010-12-06

Related Finance Registrations

NCAGE Code	3U2K8	BIONEER, INC.
CAGE Code	3U2K8	BIONEER, INC.
S.A.M. Registration	3U2K8 [146242396]	BIONEER, INC.