FDA Registration
Active
🇺🇸 United States
CTK BIOTECH, INC.
Reg #: 2032682
·
FEI: 3003952975
·
Expires 2026
Products
62
Proprietary Names
205
Establishment Types
2
Classifications
62
Registration Details
- Registration Name
- CTK BIOTECH, INC.
- Registration Number
- 2032682
- FEI Number
- 3003952975
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 13855 Stowe Dr
- City
- Poway
- State
- CA
- ZIP
- 92064
- Country
- US
Owner / Operator
- Firm Name
- CTK BIOTECH, INC.
- Operator Number
- 9051784
- Address
- 13855 Stowe Dr., --
- City
- Poway
- State
- CA
- Postal Code
- 92064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2018-10-04 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2002-06-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2021-10-05 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-03-25 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2018-10-04 |
| Antiserum, Vibrio Cholerae, All Varieties | GSQ | Class 2 | Microbiology | No | 2019-07-16 |
| Atp And Creatine Kinase (Enzymatic), Creatine | JLB | Class 1 | Clinical Chemistry | No | 2020-08-20 |
| Antisera, Cf, Rubella | GOM | Class 2 | Microbiology | No | 2018-09-26 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2018-10-04 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2018-10-04 |
| Antisera, All Leptospira Spp. | GRX | Class 2 | Microbiology | No | 2018-09-26 |
| Antisera, Cf, Adenovirus 1-33 | GOA | Class 1 | Microbiology | No | 2018-09-26 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2018-09-26 |
| Antisera, All Groups, Streptococcus Spp. | GTZ | Class 1 | Microbiology | No | 2019-07-16 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2018-10-04 |
| Antigen(Complexed),Prostate Specific,(Cpsa) | NAF | Class 3 | Unknown | No | 2018-09-27 |
| Zika Virus Serological Reagents (Emergency Use) | PYS | Class N | Unknown | No | 2018-10-04 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2020-08-20 |
| Enzyme Linked Immunoabsorbent Assay, Rotavirus | LIQ | Class 1 | Microbiology | No | 2018-09-26 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2020-08-20 |
| Kit, Identification, Neisseria Gonorrhoeae | JSX | Class 1 | Microbiology | No | 2018-09-26 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2020-08-20 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2018-10-04 |
| Reagent, Leishmanii Serological | LOO | Class 1 | Microbiology | No | 2018-09-26 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2018-09-26 |
| Test, Syphilis, Treponemal | MTN | Class N | Unknown | No | 2018-09-26 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2018-09-26 |
| Antiserum, Cf, Cytomegalovirus | GQI | Class 2 | Microbiology | No | 2018-09-26 |
| Antisera, If, Toxoplasma Gondii | LJK | Class 2 | Microbiology | No | 2018-09-26 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2020-08-20 |
| Antigen, Iha, T. Cruzi | GND | Class 1 | Microbiology | No | 2018-09-26 |
| Dengue Nucleic Acid Amplification Assay (Naat) | OZB | Class 2 | Microbiology | No | 2018-10-04 |
| Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 | OPM | Class 2 | Microbiology | No | 2018-09-26 |
| Reagents, Zika Virus Nucleic Acid | POA | Class N | Unknown | No | 2018-10-04 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2018-09-26 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2018-09-26 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2018-10-04 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2018-10-04 |
| Blood, Occult, Enzymatic Method, In Urine | JIP | Class 2 | Hematology | No | 2018-10-04 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-03-11 |
| Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies | NWY | Class N | Unknown | No | 2018-09-26 |
| Plasmodium Spp. Detection Reagents | OAX | Class 2 | Microbiology | No | 2018-09-26 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2018-09-26 |
| Dengue Virus Antigen Assay | QCU | Class 2 | Microbiology | No | 2018-09-26 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-03-25 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2020-08-20 |
| Kit, Serological, Positive Control | MJX | Class 1 | Clinical Chemistry | No | 2018-10-04 |
| Assay, Direct, Nucleic Acid Amplification, Influenza Virus | NIA | Class 1 | Microbiology | No | 2018-10-04 |
| Antiserum, Fluorescent, Mycobacterium Tuberculosis | GRT | Class 1 | Microbiology | No | 2018-09-26 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2018-09-26 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2018-09-26 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2018-12-11 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2018-10-04 |
| Antigen, Cf, Psittacosis (Chlamydia Group) | GPW | Class 1 | Microbiology | No | 2018-09-26 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2021-07-27 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2018-10-04 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2018-10-04 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2018-10-04 |
| Antisera, Cf, Herpesvirus Hominis 1,2 | GQO | Class 2 | Microbiology | No | 2018-09-26 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2018-10-04 |
| Antigens, All Groups, Salmonella Spp. | GRL | Class 2 | Microbiology | No | 2019-07-16 |
| Antisera, Cf, Influenza Virus A, B, C | GNW | Class 1 | Microbiology | No | 2018-09-26 |
Proprietary Names
CTK Ferritin ELISA (REF# E5010)
RecombiLISA Total T3 ELISA (REF# E1010)
RaFIA T3 FIA Test (REF# F1015)
RapidLight Total T3 CLIA Test (REF# L1015)
OnSite HIV 1/2 Ab Rapid Test (Ref# R0012C)
RaFIA cTnI FIA Test (REF# F3002)
OnSite Rotavirus Ag Rapid Test (REF# R0194C)
Aridia T. pallidum Real-Time PCR Test (REF# P0030H/L)
RecombiLISA Toxo IgM ELISA (REF# E0230)
RecombiLISA Leishmania Ab ELISA (REF# E0121)
RaFIA CEA FIA Test (REF# F2015)
OnSite Rota/Adeno Ag Rapid Test (REF# R0196C)
Aridia Chikungunya Virus Real-Time PCR Test (REF# P0066H/L)
OnSite Typhoid IgG/IgM Rapid Test (REF# R0160C)
RaFIA HbA1c FIA Test (REF# F6100)
RaFIA AFP FIA Test (REF# F2030)
RaFIA beta-hCG FIA Test (REF# F1000)
OnSite HCV Ab Plus Rapid Test (REF# R0023S)
OnSite Toxo IgG/IgM Rapid Test (REF# R0233S)
Aridia Dengue Serotyping Real-Time PCR Test (REF# P0061H/L)
OnSite hCG Combo Rapid Test (REF# R1001S)
RecombiLISA HBeAb ELISA (REF# E0721)
OnSite HBsAg Rapid Test (REF# R0040C)
OnSite HBsAg Rapid Test (REF# R0040S)
RaFIA AMH FIA Test (REF# F1240)
RaFIA Ferritin FIA Test (Ref# F5010)
RecombiLISA Total T4 ELISA (REF# E1020)
RecombiLISA HBeAg ELISA (REF# E0720)
RapidLight FSH CLIA Test (REF# L1100)
RapidLight hs-cTnI CLIA Test (REF# L3003)
OnSite Filarisis IgG/IgM Combo Rapid Test (REF# R0151C)
OnSite RF Rapid Test (REF# R0310C)
RapidLight TSH CLIA Test (REF# L1030)
OnSite Leishmania IgG/IgM Combo Rapid Test (REF# R0121C)
OnSite HCV Ab Plus Combo Rapid Test (REF# R0024C-CE)
OnSite HIV/Syphilis Ab Combo Rapid Test (REF# R0035C)
OnSite CMV IgG/IgM Rapid Test (REF# R0224C)
OnSite HSV-1 IgG/IgM Rapid Test (REF# R0203C)
Aridia HSV1/HSV2/T. pallidum Real-Time PCR Test (REF# P0218H/L)
RapidLight NT-proBNP CLIA Test (REF# L3050)
OnSite Chlamydia Ag Rapid Test (REF# R0080C)
RecombiLISA Free T3 ELISA (REF#E1011)
OnSite HBsAg Combo Rapid Test (REF# R0042C-CE)
OnSite hCG Urine Rapid Test (REF# R1000S)
RaFIA Estradiol FIA Test (REF# F1230)
Aridia Dengue Virus Real-Time PCR Test (REF# P0060H/L)
OnSite Syphilis Ab Combo Rapid Test (REF# R0031C)
OnSite HBsAg Combo Rapid Test (REF# R0042C)
RaFIA tPSA FIA Test (REF# F2003)
RaFIA FSH FIA Test (REF#F1100)
OnSite Syphilis Ab Rapid Test (REF# R0030S)
RapidLight Ferritin CLIA Test (REF# L5010)
RapidLight Testosterone CLIA Test (REF# L1210)
RaFIA PCT FIA Test (REF# F0400)
Aridia COVID-19 Real-Time PCR Test (REF# P0180)
OnSite HIV/Syphilis/HBV/HCV Panel Rapid Test (REF# R0038C)
OnSite S. Typhi/Paratyphi Ag Rapid Test (REF# R0162C)
RecombiLISA Dengue IgG ELISA (REF# E0311)
OnSite HAV IgM Rapid Test (REF# R0090C)
RaFIA MYO FIA Test (REF# F3030)
OnSite Duo CMV IgG-IgM Rapid Test (REF# R0223C)
RaFIA T4 FIA Test (REF# F1025)
OnSite H. Pylori Ab Combo Rapid Test (REF# R0191C)
OnSite FOB Hi Rapid Test (REF# R2011C)
RapidLight cTnI CLIA Test (REF# L3002)
OnSite FOB Rapid Test (REF# R2010C)
OnSite Rubella IgG/IgM Rapid Test (REF# R0243C)
OnSite HEV IgM Rapid Test (REF# R0095C)
OnSite HCV Ab Plus Rapid Test (REF# R0023C)
OnSite Influenza A/B Ag Rapid Test (REF# R0187C)
RaFIA MAU FIA Test (REF# F2020)
OnSite COVID-19 + Influenza A/B Ag Rapid Test (REF# R0188C)
OnSite Leishmania Ab Rapid Test (REF# R0122S)
RecombiLISA HBsAb ELISA (REF# E0711)
RecombiLISA HIV 1+2 Ab ELISA (REF# E0410)
Aridia Influenza A Typing Real-Time PCR Test (REF# P0188H/L)
OnSite Duo Dengue Ag - IgG/IgM Rapid Test (REF# R0062C)
OnSite Influenza A/B Rapid Test with Positivia External Controls (Ref# R0181S)
RecombiLISA Leptospira IgM ELISA (REF#E0330)
RaFIA CRP FIA Test (REF# F0410)
RecombiLISA HBcAb ELISA (REF# E0810)
RaFIA Cys-C FIA Test (REF# F2021)
RapidLight free T4 CLIA Test (REF# L1026)
RapidLight CK-MB CLIA Test (REF# L3020)
RapidLight Progesterone CLIA Test (REF# L1220)
RaFIA LH FIA Test (REF#F1090)
OnSite Toxo IgG/IgM Combo Rapid Test (REF# R0234C)
RapidLight Total Vitamin D CLIA Test (REF# L8010)
RapidLight Vitamin B12 CLIA Test (REF# L8030)
RecombiLISA Syphilis Ab ELISA (REF# E0610)
OnSite HBsAg/HCV Ab Rapid Test (REF# R0028C)
RaFIA D-Dimer FIA Test (REF# F3010)
Aridia West Nile Virus Real-Time PCR Test (REF# P0148H/L)
OnSite hCG Urine Rapid Test (REF# R1000C)
OnSite COVID-19 Ag Self Test (Ref# R0182CST)
Aridia Influenza A/B & RSV Real-Time PCR Test (REF# P0187H/L)
OnSite Strep A Rapid Test (REF# R0184S)
Aridia Total Nucleic Acid Isolation Kit (REF# IK010)
OnSite HIV 1/2 Ab Plus Combo Rapid Test (REF# R0011C-CE)
OnSite HIV Ag/Ab 4th Gen Rapid Test (REF# R0018C)
RecombiLISA HBc IgM ELISA (REF# E0811)
RapidLight PCT CLIA Test (REF# L0400)
RecombiLISA TSH ELISA (REF# E1030)
Aridia HPV 16/18 Real-Time PCR Test (REF# P0036H/L)
RaFIA fPSA FIA Test (REF# F2004)
OnSite Influenza A/B Rapid Test (REF# R0187S)
OnSite Duo HSV-1/2 IgG/IgM Rapid Test (REF# R0218C)
Aridia Rhinovirus/Enterovirus Real-Time PCR Test (REF# P0182H/L)
RecombiLISA Dengue Ag ELISA (REF# E0312)
RapidLight Folate CLIA Test (REF# L8020)
RaFIA NT-proBNP FIA Test (REF# F3050)
RapidLight beta-hCG CLIA Test (REF# L1000)
RapidLight Myoglobin CLIA Test (REF# L3030)
OnSite Adenovirus Ag Rapid Test (REF# R0189C)
RecombiLISA HIV 1+2 Ag-Ab ELISA (REF# E0420)
RecombiLISA Toxo IgG ELISA (REF# E0231)
OnSite PSA Semi-quantitative Rapid Test (REF# R2002C)
RapidLight D-Dimer CLIA Test (REF# L3010)
OnSite Leptospira IgG/IgM Combo Rapid Test (REF# R0101C)
RecombiLISA Free T4 ELISA (REF# E1021)
RecombiLISA HCV Ab ELISA (REF# E0511)
OnSite Malaria Pf Ag Rapid Test (REF# R0114C)
OnSite HAV IgG/IgM Rapid Test (REF# R0092C)
OnSite Chagas Ab Combo Rapid Test (REF# R0171C)
OnSite Dengue IgG Rapid Test (REF# R0065C)
RapidLight Total T4 CLIA Test (REF# L1025)
OnSite hCG Combo Rapid Test (REF# R1001C)
RapidLight free T3 CLIA Test (REF# L1016)
OnSite Syphilis Ab Rapid Test (REF# R0030C)
RecombiLISA HAV IgM ELISA (REF# E0100)
RecombiLISA HBsAg ELISA (REF# E0710)
OnSite Dengue IgG/IgM Combo Rapid Test (REF# R0061C)
RaFIA Total Vitamin D FIA (REF# F8010)
OnSite HBV-5 Rapid Test (REF# R0049C)
RecombiLISA Chagas IgG ELISA (REF# E0170)
OnSite RSV Ag Rapid Test (REF# R0186C)
Aridia Zika Virus Real-Time PCR Test (REF# P0070H/L)
OnSite HSV-2 IgG/IgM Rapid Test (REF# R0213C)
OnSite H. Pylori Ag Rapid Test (REF# R0192C)
RapidLight AMH CLIA Test (REF# L1240)
OnSite Dengue Ag Rapid Test (REF# R0063C)
OnSite Toxo IgG/IgM Rapid Test (REF# R0233C)
Aridia Zika/Dengue/CHIK Real-Time PCR Test (REF# P0071H/L)
RecombiLISA HEV IgM ELISA (REF# E0105)
OnSite Malaria Pf/Pv Ab Combo Rapid Test (REF# R0111C)
OnSite HIV 1/2 Ab Plus Combo Rapid Test (REF# R0011C)
OnSite Malaria Pf /Pv Ag Rapid Test (REF# R0112C)
OnSite Cholera Ag Rapid Test (REF# R0130C)
RaFIA COVID-19 Ag FIA Test (REF# F0182)
RaFIA TSH FIA Test (REF# F1030)
OnSite Malaria Pf / Pan Ag Rapid Test (REF# R0113C)
RapidLight PRL CLIA Test (REF# L1080)
RaFIA Progesterone FIA Test (REF#F1220)
OnSite Strep A Rapid Test (REF# R0184C)
OnSite Troponin I Combo Rapid Test (REF# R3002C)
RapidLight E2 CLIA Test (REF# L1230)
RecombiLISA CHIK IgM ELISA (REF# E0315)
RaFIA CK-MB FIA Test (REF# F3020)
RecombiLISA Zika IgM ELISA (REF# E0320)
OnSite TORCH Panel Rapid Test (REF#R0253C)
RaFIA PRL FIA Test (REF#F1080)
OnSite Typhoid IgG/IgM Combo Rapid Test (REF# R0161C)
RaFIA Total IgE FIA Test (Ref# F5020)
OnSite Duo Dengue IgG/IgM-CHIK IgM Rapid Test (REF# R0069C)
OnSite Troponin I Rapid Test (REF# R3001C)
RaFIA Testosterone FIA Test (REF#F1210)
RapidLight LH CLIA Test (REF# L1090)
OnSite HCV Ab Plus Combo Rapid Test (REF# R0024C)
OnSite COVID-19 Ag Rapid Test (Ref# R0182C)
RecombiLISA Dengue IgM ELISA (REF# E0310)
RecombiLISA HCV IgG ELISA (REF# E0510)
OnSite Chikungunya IgM Combo Rapid Test (REF# R0066C)
OnSite COVID-19 IgG/IgM Rapid Test (REF# R0180C)
OnSite TB IgG/IgM Combo Rapid Test (REF# R0053C)
OnSite H. Pylori Ag Rapid Test (REF# R0192S)
CTK Progesterone ELISA (REF# E1220)
OnSite Cholera Ag Rapid Test (REF# R0130C)
CTK Testosterone ELISA (REF# E1210)
Aria Strep A Rapid Test
OnSite Strep A Rapid Test
OnSite Gonorrhea Rapid Test
CTK PRL ELISA (REF# E1080)
OnSite Leishmania Ab Rapid Test (REF# R0122S)
CTK Estradiol (E2) ELISA (REF# E1230)
ImmuView COVID-19 Antigen Home Test (REF# R0182CHT)
OnSite Duo Dengue Ag - IgG/IgM Rapid Test (REF# R0062C)
Positivia Malaria Ag Rapid Test External Control Kit (REF# C0010)
Positivia FOB Rapid Test External Control Kit (REF# C2011)
Positivia HIV P24 Ag Rapid Test External Control Kit (REF# C0018)
Positivia COVID-19 Ag Rapid Test External Control Kit (REF# C0182)
Positivia Dengue Ag Rapid Test External Control Kit (REF# C0063)
Positivia H. pylori Ag Rapid Test External Control Kit (REF# C0192)
Positivia Influenza A/B Rapid Test External Control Kit (REF# C0187)
Positivia Dengue IgG Rapid Test External Control Kit (REF# C0065)
OnSite HIV 1/2 Ab Plus Combo Rapid Test (REF# R0011C)
ALTA CLIAlyzer Automatic Chemiluminescence Analyzer (REF# CLIA-1)
RaFIA II Immunofluorescence Analyzer (REF# FIA-102)
ALTA Rapid Test Reader (REF# RTR-1)
RaFIA Immunofluorescence Analyzer (REF# FIA-100)
ALTA ELISA Reader (REF# ADX-110)
ALTA Microplate Washer (REF# ADX-120)
RaFIA II Semi-automated Immunofluorescence Analyzer (REF# FIA-103)
RaFIA Immunofluorescence Incubator (REF# FIA-101)
CTK FSH ELISA (REF# E1100)
CTK LH ELISA (REF# E1090)
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device