Biocheck Inc

FDA Filings

This page includes the latest FDA filings for Biocheck 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: 2953756
• FEI Number: 3002564473
• Name: BIOCHECK, INC.
• Owner & Operator: BIOCHECK, INC.
• Contact Address: 425 Eccles Avenue --; South San Francisco CA 94080 US
• Official Correspondent:
  • Amy - Zhang
  • 1-650-5731968-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 425 Eccles Avenue ; South San Francisco, CA 94080 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00850392007619 BIOCHECK, INC.	BioCheck Beta-2 Microglobulin EIA Test Kit BC-1061	2019-10-16
GUDID 00850392007350 BIOCHECK, INC.	BioCheck IgE EIA Test Kit BC-1035	2019-10-16
GUDID 00850392007275 BIOCHECK, INC.	BioCheck hCG EIA Test Kit BC-1027	2019-10-16
GUDID 00850392007251 BIOCHECK, INC.	BioCheck Human Ferritin EIA Test Kit BC-1025	2019-10-16
GUDID 00850392007190 BIOCHECK, INC.	BioCheck High Sensitive CRP EIA Test Kit BC-1119	2019-10-16
GUDID 00850392007176 BIOCHECK, INC.	BioCheck Myoglobin EIA Test Kit BC-1117	2019-10-16
GUDID 00850392007077 BIOCHECK, INC.	BioCheck T4 EIA Test Kit BC-1007	2019-10-16
GUDID 00850392007053 BIOCHECK, INC.	BioCheck T3 EIA Test Kit BC-1005	2019-10-16
GUDID 00850392007039 BIOCHECK, INC.	BioCheck U-TSH EIA Test Kit BC-1003	2019-10-16
GUDID 00850392007015 BIOCHECK, INC.	BioCheck TSH EIA Test Kit BC-1001	2019-10-16
GUDID 00850392007152 BIOCHECK, INC.	BioCheck Testosterone EIA Test Kit BC-1115	2019-08-07
PMN DEN170045 | QAT BIOCHECK, INC.	Banyan BTI	2018-11-02
PMN K111452 | OYG BIOCHECK, INC.	Presage ST2 Assay Kit, Presage ST2 Assay Kit Controls	2013-11-06
PMN K111452 | JJX BIOCHECK, INC.	Presage ST2 Assay Kit, Presage ST2 Assay Kit Controls	2013-11-06
PMN K992528 | DGC BIOCHECK, INC.	BioCheck IgE ELISA Kit	2007-12-05
PMN K992517 | DBF BIOCHECK, INC.	BioCheck Ferritin ELISA Kit	2007-12-05
PMN K991741 | JHI BIOCHECK, INC.	BioCheck hCG ELISA Kit	2007-12-05
PMN K991432 | KLI BIOCHECK, INC.	BioCheck T4 EIA Kit	2007-12-05
PMN K991311 | CDP BIOCHECK, INC.	BioCheck T3 EIA Kit	2007-12-05
PMN K991146 | JLW BIOCHECK, INC.	BioCheck TSH ELISA Kit	2007-12-05
PMN K990993 | JLW BIOCHECK, INC.	BioCheck S-TSH ELISA Kit	2007-12-05
PMN K022660 | DRR BIOCHECK, INC.	BioCheck Myoglobin ELISA Kit	2007-12-05
PMN K013062 | MMI BIOCHECK, INC.	BioCheck Troponin I EIA Test Kit	2007-12-05
PMN K003851 | DCK BIOCHECK, INC.	BioCheck HS-CRP ELISA Kit	2007-12-05
PMN K002294 | CDZ BIOCHECK, INC.	BioCheck Testosterone EIA Kit	2007-12-05
PMN K001022 | JZG BIOCHECK, INC.	BioCheck Beta-2 Microglobulin ELISA	2007-12-05
PMN K041619 BIOCHECK, INC.	BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116	2004-12-17
PMN K040030 BIOCHECK, INC.	BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114	2004-06-16
PMN K022660 BIOCHECK, INC.	BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117	2002-12-19
PMN K013062 BIOCHECK, INC.	BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT	2002-01-08
PMN K003851 BIOCHECK, INC.	BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119	2001-07-20
JLS BIOCHECK, INC.	BIOCHECK PROGESTERONE EIA TEST KIT	2001-04-25
CHP BIOCHECK, INC.	BIOCHECK ESTRADIOL EIA TEST KIT	2001-04-25
PMN K002294 BIOCHECK, INC.	BIOCHECK TESTOSTERONE EIA, MODEL BC-1115	2000-10-02
PMN K001022 BIOCHECK, INC.	BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061	2000-09-26
PMN K992517 BIOCHECK, INC.	BIOCHECK FERRITIN ELISA MODEL BC-1025	1999-09-24
PMN K992528 BIOCHECK, INC.	BIOCHECK IGE ELISA, MODEL BC-1035	1999-09-21
PMN K991741 BIOCHECK, INC.	BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027	1999-07-22
PMN K991146 BIOCHECK, INC.	TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001	1999-06-22
PMN K990993 BIOCHECK, INC.	BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003	1999-06-22
PMN K991432 BIOCHECK, INC.	BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007	1999-06-02
PMN K991311 BIOCHECK, INC.	TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005	1999-06-02
CGJ BIOCHECK, INC.	BioCheck FSH EIA Test Kit	1998-04-22
CFT BIOCHECK, INC.	BIOCHECK PROLACTIN EIA TEST KIT	1998-04-22
CFL BIOCHECK, INC.	HGH EIA TEST KIT	1998-04-22
CFL BIOCHECK, INC.	BIOCHECK	1998-04-22
CEP BIOCHECK, INC.	BIOCHECK LH EIA TEST KIT	1998-04-22
CDP BIOCHECK, INC.	BIOCHECK T3 EIA TEST KIT	1998-04-22

Related Finance Registrations

NCAGE Code	80DG5	BIOCHECK, INC.
CAGE Code	80DG5	BIOCHECK, INC.
S.A.M. Registration	80DG5 [171857493]	BIOCHECK, INC.