Ctk Biotech Inc

FDA Filings

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

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

• BEIJING GENESEE BIOTECH, INC.

FDA Registration(s)

• Registration Number: 2032682
• FEI Number: 3003952975
• Name: CTK BIOTECH, INC.
• Owner & Operator: CTK BIOTECH, INC.
• Contact Address: 10110 Mesa Rim Road. --; San Diego CA 92121 US
• Official Correspondent:
  • CATHERINE Y CHEN
  • x-858-4578698-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 13855 Stowe Dr ; Poway, CA 92064 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00855402007979 CTK BIOTECH INC.	ImmuView COVID-19 Antigen Home Test R0182CHT	2023-06-16
GUDID 00855402007962 CTK BIOTECH INC.	ImmuView COVID-19 Antigen Home Test R0182CHT	2023-06-16
GUDID 00855402007955 CTK BIOTECH INC.	ImmuView COVID-19 Antigen Home Test R0182CHT	2023-06-16
QKO CTK BIOTECH, INC.	OnSite COVID-19 IgG/IgM Rapid Test	2020-03-25
QKO CTK BIOTECH, INC.	Aria COVID-19 IgG/IgM Rapid Test	2020-03-25
QJR CTK BIOTECH, INC.	Aridia COVID-19 Real-Time PCR Test	2020-03-25
LIQ CTK BIOTECH, INC.	OnSite Rotavirus Ag Rapid Test (REF# R0194C)	2019-07-16
LIQ CTK BIOTECH, INC.	OnSite Rota/Adeno Ag Rapid Test (REF# R0196C)	2019-07-16
GTZ CTK BIOTECH, INC.	OnSite Strep A Rapid Test (REF# R0184S)	2019-07-16
GTZ CTK BIOTECH, INC.	OnSite Strep A Rapid Test (REF# R0184C)	2019-07-16
GSQ CTK BIOTECH, INC.	OnSite Cholera Ag Rapid Test (REF# R0130C)	2019-07-16
GRX CTK BIOTECH, INC.	OnSite Leptospira IgG/IgM Combo Rapid Test (REF# R0101C)	2019-07-16
GRL CTK BIOTECH, INC.	OnSite Typhoid IgG/IgM Rapid Test (REF# R0160C)	2019-07-16
GRL CTK BIOTECH, INC.	OnSite Typhoid IgG/IgM Combo Rapid Test (REF# R0161C)	2019-07-16
GRL CTK BIOTECH, INC.	OnSite S. Typhi/Paratyphi Ag Rapid Test (REF# R0162C)	2019-07-16
GQG CTK BIOTECH, INC.	OnSite RSV Rapid Test (REF# R0188S)	2019-07-16
GOA CTK BIOTECH, INC.	OnSite Rota/Adeno Ag Rapid Test (REF# R0196C)	2019-07-16
GNW CTK BIOTECH, INC.	OnSite Influenza A/B Rapid Test (REF# R0187S)	2019-07-16
GNW CTK BIOTECH, INC.	OnSite Influenza A/B Rapid Test (REF# R0187C)	2019-07-16
NSU CTK BIOTECH, INC.	ALTA Rapid Test Reader (REF# RTR-1)	2018-12-11
NSU CTK BIOTECH, INC.	ALTA Microplate Washer (REF# ADX-120)	2018-12-11
NSU CTK BIOTECH, INC.	ALTA ELISA Reader (REF# ADX-110)	2018-12-11
PYS CTK BIOTECH, INC.	Zika IgM ELISA	2018-10-04
POA CTK BIOTECH, INC.	Zika Virus Real-Time PCR Test	2018-10-04
OZB CTK BIOTECH, INC.	Zika/Dengue/CHIK Real-Time PCR Test	2018-10-04
OZB CTK BIOTECH, INC.	Dengue Virus Real-Time PCR Test	2018-10-04
OZB CTK BIOTECH, INC.	Dengue Serotyping Real-Time PCR Test	2018-10-04
NIA CTK BIOTECH, INC.	Influenza A/B & RSV Real-Time PCR Test	2018-10-04
MRG CTK BIOTECH, INC.	Vitamin D (Total) ELISA	2018-10-04
MMI CTK BIOTECH, INC.	Troponin I Rapid Test	2018-10-04
MMI CTK BIOTECH, INC.	Troponin I Combo Rapid Test	2018-10-04
JSY CTK BIOTECH, INC.	HEV IgM Rapid Test	2018-10-04
JSY CTK BIOTECH, INC.	HEV IgM ELISA	2018-10-04
JSY CTK BIOTECH, INC.	HEV IgG/IgM Rapid Test	2018-10-04
JSY CTK BIOTECH, INC.	Filarisis IgG/IgM Combo Rapid Test	2018-10-04
JSY CTK BIOTECH, INC.	Chikungunya Virus Real-Time PCR Test	2018-10-04
JSY CTK BIOTECH, INC.	Chikungunya IgM Combo Rapid Test	2018-10-04
JSY CTK BIOTECH, INC.	CHIK IgM ELISA	2018-10-04
JMG CTK BIOTECH, INC.	Ferritin ELISA	2018-10-04
JLW CTK BIOTECH, INC.	TSH ELISA	2018-10-04
JIP CTK BIOTECH, INC.	FOB Rapid Test	2018-10-04
JIP CTK BIOTECH, INC.	FOB Hi Rapid Test	2018-10-04
JHI CTK BIOTECH, INC.	hCG ELISA	2018-10-04
CEC CTK BIOTECH, INC.	Free T4 ELISA	2018-10-04
CDZ CTK BIOTECH, INC.	Testosterone ELISA	2018-10-04
CDD CTK BIOTECH, INC.	Vitamin B12 ELISA	2018-10-04
NAF CTK BIOTECH, INC.	PSA Semi-quantitative Rapid Test	2018-09-27
QCU CTK BIOTECH, INC.	Duo Dengue Ag - IgG/IgM Rapid Test	2018-09-26
QCU CTK BIOTECH, INC.	Dengue Ag Rapid Test	2018-09-26
QCU CTK BIOTECH, INC.	Dengue Ag ELISA	2018-09-26
OPM CTK BIOTECH, INC.	TORCH Panel Rapid Test	2018-09-26
OAX CTK BIOTECH, INC.	Malaria Pf/Pv Ab Rapid Test	2018-09-26
OAX CTK BIOTECH, INC.	Malaria Pf/Pv Ab Combo Rapid Test	2018-09-26
OAX CTK BIOTECH, INC.	Malaria Pf /Pv Ag Rapid Test	2018-09-26
OAX CTK BIOTECH, INC.	Malaria Pf / Pan Ag Rapid Test	2018-09-26
NWY CTK BIOTECH, INC.	Duo Dengue IgG/IgM-CHIK IgM Rapid Test	2018-09-26
NWY CTK BIOTECH, INC.	Dengue IgM ELISA	2018-09-26
NWY CTK BIOTECH, INC.	Dengue IgG/IgM Combo Rapid Test	2018-09-26
NWY CTK BIOTECH, INC.	Dengue IgG ELISA	2018-09-26
MZO CTK BIOTECH, INC.	HCV IgG ELISA	2018-09-26
MZO CTK BIOTECH, INC.	HCV Ab Plus Rapid Test	2018-09-26
MZO CTK BIOTECH, INC.	HCV Ab Plus Combo Rapid Test	2018-09-26
MZO CTK BIOTECH, INC.	HCV Ab ELISA	2018-09-26
MZF CTK BIOTECH, INC.	HIV/Syphilis/HBV/HCV Panel Rapid Test	2018-09-26
MZF CTK BIOTECH, INC.	HIV/Syphilis Ab Combo Rapid Test	2018-09-26
MZF CTK BIOTECH, INC.	HIV Ag/Ab 4th Gen Rapid Test	2018-09-26
MZF CTK BIOTECH, INC.	HIV 1/2 Ab Plus Combo Rapid Test	2018-09-26
MZF CTK BIOTECH, INC.	HIV 1+2 Ag-Ab ELISA	2018-09-26
MZF CTK BIOTECH, INC.	HIV 1+2 Ab ELISA	2018-09-26
MTN CTK BIOTECH, INC.	Syphilis Ab Rapid Test	2018-09-26
MTN CTK BIOTECH, INC.	Syphilis Ab ELISA	2018-09-26
MTN CTK BIOTECH, INC.	Syphilis Ab Combo Rapid Test	2018-09-26
LYR CTK BIOTECH, INC.	H. Pylori Ag Rapid Test	2018-09-26
LYR CTK BIOTECH, INC.	H. Pylori Ab Combo Rapid Test	2018-09-26
LOO CTK BIOTECH, INC.	Leishmania IgG/IgM Combo Rapid Test	2018-09-26
LOO CTK BIOTECH, INC.	Leishmania Ab Rapid Test	2018-09-26
LOO CTK BIOTECH, INC.	Leishmania Ab ELISA	2018-09-26
LOM CTK BIOTECH, INC.	HBsAg/HCV Ab Rapid Test	2018-09-26
LOM CTK BIOTECH, INC.	HBsAg Rapid Test	2018-09-26
LOM CTK BIOTECH, INC.	HBsAg ELISA	2018-09-26
LOM CTK BIOTECH, INC.	HBsAg Combo Rapid Test	2018-09-26
LOM CTK BIOTECH, INC.	HBsAb ELISA	2018-09-26
LOM CTK BIOTECH, INC.	HBeAg ELISA	2018-09-26
LOM CTK BIOTECH, INC.	HBeAb ELISA	2018-09-26
LOM CTK BIOTECH, INC.	HBcAb ELISA	2018-09-26
LOM CTK BIOTECH, INC.	HBc IgM ELISA	2018-09-26
LOM CTK BIOTECH, INC.	HBV-5 Rapid Test	2018-09-26
LOL CTK BIOTECH, INC.	HAV IgM Rapid Test	2018-09-26
LOL CTK BIOTECH, INC.	HAV IgM ELISA	2018-09-26
LOL CTK BIOTECH, INC.	HAV IgG/IgM Rapid Test	2018-09-26
LJK CTK BIOTECH, INC.	Toxo IgM ELISA	2018-09-26
LJK CTK BIOTECH, INC.	Toxo IgG/IgM Rapid Test	2018-09-26
LJK CTK BIOTECH, INC.	Toxo IgG/IgM Combo Rapid Test	2018-09-26
LJK CTK BIOTECH, INC.	Toxo IgG ELISA	2018-09-26
GRT CTK BIOTECH, INC.	TB IgG/IgM Rapid Test	2018-09-26
GRT CTK BIOTECH, INC.	TB IgG/IgM Combo Rapid Test	2018-09-26
GQO CTK BIOTECH, INC.	HSV-2 IgG/IgM Rapid Test	2018-09-26
GQO CTK BIOTECH, INC.	HSV-1 IgG/IgM Rapid Test	2018-09-26
GQO CTK BIOTECH, INC.	Duo HSV-1/2 IgG/IgM Rapid Test	2018-09-26
GQI CTK BIOTECH, INC.	Duo CMV IgG-IgM Rapid Test	2018-09-26
GQI CTK BIOTECH, INC.	CMV IgG/IgM Rapid Test	2018-09-26
GPW CTK BIOTECH, INC.	Chlamydia Ag Rapid Test	2018-09-26
GOM CTK BIOTECH, INC.	Rubella IgG/IgM Rapid Test	2018-09-26
GND CTK BIOTECH, INC.	Chagas IgG ELISA	2018-09-26
GND CTK BIOTECH, INC.	Chagas Ab Combo Rapid Test	2018-09-26
DHR CTK BIOTECH, INC.	RF Rapid Test	2018-09-26
DHA CTK BIOTECH, INC.	hCG Combo Rapid Test	2018-09-26
MJX CTK BIOTECH, INC.	Malaria Ag Rapid Test External Control Kit (REF# C0010)	2017-08-02
MJX CTK BIOTECH, INC.	Influenza A/B Rapid Test External Control Kit (REF# C0187)	2017-08-02
MJX CTK BIOTECH, INC.	HIV P24 Ag Rapid Test External Control Kit (REF# C0018)	2017-08-02
MJX CTK BIOTECH, INC.	H. pylori Ag Rapid Test External Control Kit (REF# C0192)	2017-08-02
MJX CTK BIOTECH, INC.	FOB Rapid Test External Control Kit (REF# C2011)	2017-08-02
MJX CTK BIOTECH, INC.	Dengue Ag Rapid Test External Control Kit (REF# C0063)	2017-08-02
KLI CTK BIOTECH, INC.	Total T4 ELISA (REF# E1020)	2016-07-13
KLI CTK BIOTECH, INC.	Free T4 ELISA (REF# E1021)	2016-07-13
JLS CTK BIOTECH, INC.	CTK Progesterone ELISA (REF# E1220)	2005-01-07
CHP CTK BIOTECH, INC.	CTK Estradiol (E2) ELISA (REF# E1230)	2005-01-07
CGJ CTK BIOTECH, INC.	CTK FSH ELISA (REF# E1100)	2005-01-07
CEP CTK BIOTECH, INC.	CTK LH ELISA (REF# E1090)	2005-01-07
CFT CTK BIOTECH, INC.	CTK PRL ELISA (REF# E1080)	2002-06-21
CDP CTK BIOTECH, INC.	Total T3 ELISA (REF# E1010)	2002-06-21
CDP CTK BIOTECH, INC.	Free T3 ELISA (REF#E1011)	2002-06-21

Related Finance Registrations

NCAGE Code	601F7	CTK BIOTECH INC
CAGE Code	601F7	CTK BIOTECH INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090947984	Pusan,South Korea -> Los Angeles, California	EMPTY FORM CARTON	21 CTN
2020090142305	Shanghai ,China (Mainland) -> Long Beach, California	DETECTION CARD ASSEMBLY EQUIPMENT PACKING EQUIPMENT VIBRATION BOWL FEEDER ACCESSORIES	5 PKG
2020073130016	Xingang,China (Mainland) -> Long Beach, California	MEDICAL DIAGNOSTIC KIT IMPORT FOR EXPORT	270 CTN
2020071162830	Pusan,South Korea -> Long Beach, California	PLASTIC ELISA BOXES ELISA PAPER KIT BOX BOTTL E WITH CAP LABEL FOAM INSERT WORKING SHEET EL ISA PLATE ELISA SELF-SEALING POUCH SYPHILIS A B COMBO RAPID TEST CS UNCUT CASSETTES POUCH	111 CTN
2020071059132	Pusan,South Korea -> Long Beach, California	PLASTIC ELISA BOXES ELISA PAPER KIT BOX BOTTL E WITH CAP LABEL FOAM INSERT WORKING SHEET EL ISA PLATE ELISA SELF-SEALING POUCH SYPHILIS A B COMBO RAPID TEST CS UNCUT CASSETTES POUCH	111 CTN
2020070952449	Pusan,South Korea -> Long Beach, California	PLASTIC ELISA BOXES ELISA PAPER KIT BOX BOTTL E WITH CAP LABEL FOAM INSERT WORKING SHEET EL ISA PLATE ELISA SELF-SEALING POUCH SYPHILIS A B COMBO RAPID TEST CS UNCUT CASSETTES POUCH	111 CTN
2020070455111	Pusan,South Korea -> Long Beach, California	PLASTIC ELISA BOXES ELISA PAPER KIT BOX BOTTL E WITH CAP LABEL FOAM INSERT WORKING SHEET EL ISA PLATE ELISA SELF-SEALING POUCH SYPHILIS A B COMBO RAPID TEST CS UNCUT CASSETTES POUCH	111 CTN
2020070321205	Pusan,South Korea -> Los Angeles, California	MEDICAL DIAGNOSTIC KIT IMPORT FOR EXPORT	4 CTN