Applied Biocode Inc

FDA Filings

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

USA

GRE TAI SECURITY MARKET

6598

DUNS 004580003

FDA Registration(s)

• Registration Number: 3007799234
• FEI Number: 3007799234
• Name: APPLIED BIOCODE, INC.
• Owner & Operator: Applied BioCode, Inc.
• Contact Address: 12130 Mora Drive Unit #2 ; Santa Fe Springs CA 90670 US
• Official Correspondent:
  • Ingrid U Joseph
  • x-562-7779886-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 12130 Mora Drive Unit #2 Suite 102; Santa Fe Springs, CA 90670 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00851034007073 APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel 63-R0001	2020-01-20
PMN K192485 | OZZ APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OZY APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OZX APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OZE APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OTG APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OOU APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OEP APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OEM APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | OCC APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 | NSU APPLIED BIOCODE, INC.	BioCode Respiratory Pathogen Panel	2020-01-08
PMN K192485 Applied BioCode, Inc.	BioCode Respiratory Pathogen Panel (RPP)	2019-12-23
GUDID 00851034007042 APPLIED BIOCODE, INC.	BioCode SA-PE Mix Pack	2019-08-07
GUDID 00851034007035 APPLIED BIOCODE, INC.	BioCode MDx 3000 Buffer A	2019-08-07
GUDID 00851034007028 APPLIED BIOCODE, INC.	BioCode MDx 3000 Optical Calibration and Verification Kit 64-C0002	2019-08-07
PMN K190585 Applied Biocode, Inc.	Biocode Gastrointestinal Pathogen Panel (GPP)	2019-06-05
PMN K190585 | PCH APPLIED BIOCODE, INC.	BioCode Gastrointestinal Pathogen Panel (GPP)	2019-06-05
PMN K190585 | OOI APPLIED BIOCODE, INC.	BioCode Gastrointestinal Pathogen Panel (GPP)	2019-06-05
GUDID 00851034007011 APPLIED BIOCODE, INC.	Gastrointestinal Pathogen Panel (GPP) Kit	2018-11-15
GUDID 00851034007004 APPLIED BIOCODE, INC.	BioCode MDx 3000 41-A0051	2018-11-15
PMN K180041 | PCH APPLIED BIOCODE, INC.	Gastrointestinal Pathogen Panel (GPP) Kit	2018-10-08
PMN K180041 | OOI APPLIED BIOCODE, INC.	Gastrointestinal Pathogen Panel (GPP) Kit	2018-10-08
PMN K180041 Applied Biocode, Inc.	BioCode Gastrointestinal Pathogen Panel (GPP)	2018-09-28
GUDID 00851034007059 APPLIED BIOCODE, INC.	BioCode 2500 Multiplex Detection System 41-A0005	2018-09-24
JJQ APPLIED BIOCODE, INC.	BioCode 2500 Multiplex Detection System	2017-05-22

Related Finance Registrations

NCAGE Code	653K4	APPLIED BIOCODE, INC.
CAGE Code	653K4	APPLIED BIOCODE, INC.
S.A.M. Registration	653K4 [4580003]	APPLIED BIOCODE, INC.
SEC	0001553480	Applied BioCode, Inc. of CALIFORNIA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092520382	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#190642 REV1 (HS CODE: 9030.89)	7 WDC
2020091551319	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#190642 REV1 (HS CODE: 9030.89)	7 WDC
2020091486742	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#190642 REV1 (HS CODE: 9030.89)	7 WDC
202007294270	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#190642 REV1 (HS CODE: 9030.89 )	5 WDC
2020062742199	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#190642 REV1 (HS CODE: 9030.89 )	5 WDC
2020021127341	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#018829 (HS CODE: 9030.89)	3 WDC
2020020630593	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#018829 (HS CODE: 9030.89)	3 WDC
2020020531454	Kaohsiung,China (Taiwan) -> Long Beach, California	700-C2201-001 2500 ANALYZER SYSTEM CUST ITEM NO.41-A0003 PO#018829 (HS CODE: 9030.89)	3 WDC