Epitope Diagnostics Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 2032839
• FEI Number: 3004185580
• Name: EPITOPE DIAGNOSTICS, INC.
• Owner & Operator: EPITOPE DIAGNOSTICS, INC.
• Contact Address: 7110 Carroll Road --; San Diego CA 92121 US
• Official Correspondent:
  • PING - GAO
  • x-858-6937877-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7110 Carroll Rd ; SAN DIEGO, CA 92121 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
QKO EPITOPE DIAGNOSTICS, INC.	KT-1033 EDI? Novel Coronavirus COVID-19 IgM ELISA Kit	2020-03-20
QKO EPITOPE DIAGNOSTICS, INC.	KT-1032 EDI? Novel Coronavirus COVID-19 IgG ELISA Kit	2020-03-20
JJE EPITOPE DIAGNOSTICS, INC.	ECL-100	2020-01-29
PQO EPITOPE DIAGNOSTICS, INC.	Serolisa? Human Anti-Mullerian Hormone ELISA Kit	2018-01-29
DAD EPITOPE DIAGNOSTICS, INC.	EDI? HAPTOGLOBIN Immunoturbidimetric Assay	2017-10-05
CEW EPITOPE DIAGNOSTICS, INC.	Serolisa? Human Intact PTH ELISA Kit	2017-07-19
NCW EPITOPE DIAGNOSTICS, INC.	EDI? Anti- Trastuzumab (Herceptin) ELISA Kit	2015-12-14
MRG EPITOPE DIAGNOSTICS, INC.	EDI? Total 25-OH Vitamin D EIA Kit	2015-12-14
JME EPITOPE DIAGNOSTICS, INC.	EDI? Total GLP-1 ELISA Kit	2015-12-14
NXO EPITOPE DIAGNOSTICS, INC.	eCasset Calprotectin Rapid Test	2013-12-16
NXO EPITOPE DIAGNOSTICS, INC.	EpiTuub Calprotectin/i-FOB DUO Rapid Test Kit	2013-12-16
NXO EPITOPE DIAGNOSTICS, INC.	EpiTuub Calprotectin Rapid Test Kit	2013-12-16
NXO EPITOPE DIAGNOSTICS, INC.	EDI? Quantitative Fecal Calprotectin ELISA Kit	2013-12-16
NTV EPITOPE DIAGNOSTICS, INC.	EDI? Quantitative Fecal/Urine Myeloperoxidase ELISA Kit	2013-12-16
NTV EPITOPE DIAGNOSTICS, INC.	EDI? Plasma Myeloperoxidase ELISA Kit	2013-12-16
JKD EPITOPE DIAGNOSTICS, INC.	EDI? Human Ultra-Sensitive C-Peptide ELISA Kit	2013-12-16
JKD EPITOPE DIAGNOSTICS, INC.	EDI? Human C-Peptide ELISA Kit	2013-12-16
CKG EPITOPE DIAGNOSTICS, INC.	EDI? Human ACTH ELISA Kit	2013-12-16
CFL EPITOPE DIAGNOSTICS, INC.	EDI? Human Growth Hormone ELISA Kit	2012-12-10
MOI EPITOPE DIAGNOSTICS, INC.	EDI? Human Chromogranin A ELISA Kit	2010-12-27
MHJ EPITOPE DIAGNOSTICS, INC.	EpiTuub Fecal Cryptosporidium parvum Antigen Rapid Test	2010-12-27
MHJ EPITOPE DIAGNOSTICS, INC.	EDI? Fecal Cryptosporidium parvum Antigen ELISA Kit	2010-12-27
LYR EPITOPE DIAGNOSTICS, INC.	eCasset? Helicobacter pylori Antigen Rapid Test Kit	2010-12-27
LYR EPITOPE DIAGNOSTICS, INC.	Fecal H. pylori Antigen Rapid Test Strips	2010-12-27
LYR EPITOPE DIAGNOSTICS, INC.	EpiTuub Fecal H. Pylori Antigen Rapid Test Kit	2010-12-27
LYR EPITOPE DIAGNOSTICS, INC.	EDI? Fecal H. pylori Antigen ELISA Kit	2010-12-27
LKS EPITOPE DIAGNOSTICS, INC.	Fecal Ova/Parasite Sample Collection Kit	2010-12-27
LKS EPITOPE DIAGNOSTICS, INC.	Fecal Ova/Parasite Concentration Kit	2010-12-27
NEO EPITOPE DIAGNOSTICS, INC.	EDI? Human Osteocalcin (1-43/49) Specific ELISA Kit	2008-12-23
MLH EPITOPE DIAGNOSTICS, INC.	EDI? Human Anti-Mouse Antibody (HAMA) ELISA Kit	2008-12-23
MHI EPITOPE DIAGNOSTICS, INC.	EpiTuub Fecal Giardia lamblia Antigen Rapid Test	2008-12-23
MHI EPITOPE DIAGNOSTICS, INC.	EDI? Human Anti-Giardia lamblia IgM ELISA Kit	2008-12-23
MHI EPITOPE DIAGNOSTICS, INC.	EDI? Human Anti-Giardia lamblia IgG ELISA Kit	2008-12-23
MHI EPITOPE DIAGNOSTICS, INC.	EDI? Human Anti-Giardia lamblia IgA ELISA Kit	2008-12-23
PMN K051806 | KHE EPITOPE DIAGNOSTICS, INC.	CARE	2007-12-11
MST EPITOPE DIAGNOSTICS, INC.	EDI? Human Anti-Gliadin IgG ELISA Kit	2007-12-11
MST EPITOPE DIAGNOSTICS, INC.	EDI? Human Anti-Gliadin IgA ELISA Kit	2007-12-11
LIQ EPITOPE DIAGNOSTICS, INC.	EpiTuub Fecal Rotavirus Antigen Rapid Test Kit	2007-12-11
LIQ EPITOPE DIAGNOSTICS, INC.	EDI? Fecal Rotavirus Antigen Strip Test Kit	2007-12-11
LIQ EPITOPE DIAGNOSTICS, INC.	EDI? Fecal Rotavirus Antigen ELISA Kit	2007-12-11
JZO EPITOPE DIAGNOSTICS, INC.	EDI? High Sensitive Anti-Tg (Thyroglobulin) IgG ELISA Kit	2007-12-11
JZO EPITOPE DIAGNOSTICS, INC.	EDI? High Sensitive Anti-TPO ELISA Kit	2007-12-11
JNL EPITOPE DIAGNOSTICS, INC.	EDI? High Sensitive Anti-Tg (Thyroglobulin) IgG ELISA Kit	2007-12-11
GOD EPITOPE DIAGNOSTICS, INC.	EpiTuub Fecal Adenovirus Antigen Rapid Test Kit	2007-12-11
GOD EPITOPE DIAGNOSTICS, INC.	EpiTuub Fecal Adeno/Rotavirus DUO Antigen Rapid Test Kit	2007-12-11
GOD EPITOPE DIAGNOSTICS, INC.	EDI? Fecal Adenovirus Antigen ELISA Kit	2007-12-11
PMN K051806 EPITOPE DIAGNOSTICS, INC.	CARE FECAL OCCULT BLOOD TEST, MODEL KT313	2005-10-03

Related Finance Registrations

NCAGE Code	8PUW1	EPITOPE DIAGNOSTICS, INC.
DUNS	144563058	EPITOPE DIAGNOSTICS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092151393	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC TUBE	154 PKG
2020081753067	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC TUBE	102 PKG
2020072815917	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC TUBE	150 PKG
2020072440480	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC TUBE PLASTIC BOTTLE	265 CTN
2020072122960	Ningpo ,China (Mainland) -> Long Beach, California	PLASTIC BOTTLE	220 CTN
2020071341209	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC TUBE	150 PKG
2020061562860	Shanghai ,China (Mainland) -> Los Angeles, California	PLASTIC TUBE	150 PKG
2020060940195	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC BOTTLE&PLASTIC BAG	468 CTN