CTK Biotech, Inc.
Poway, CA, US
CTK BIOTECH, INC. appears in FDA device records in Poway, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 1
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032682 | 3003952975 | CTK BIOTECH, INC. | 13855 Stowe Dr, Poway, CA 92064 US | 2026 | and 52 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NAFAntigen(Complexed),Prostate Specific,(Cpsa)
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GPWAntigen, Cf, Psittacosis (Chlamydia Group)
- GNDAntigen, Iha, T. Cruzi
- GRLAntigens, All Groups, Salmonella Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- GRXAntisera, All Leptospira Spp.
- GOAAntisera, Cf, Adenovirus 1-33
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GNWAntisera, Cf, Influenza Virus A, B, C
- GOMAntisera, Cf, Rubella
- LJKAntisera, If, Toxoplasma Gondii
- GQIAntiserum, Cf, Cytomegalovirus
- GRTAntiserum, Fluorescent, Mycobacterium Tuberculosis
- GSQAntiserum, Vibrio Cholerae, All Varieties
- NIAAssay, Direct, Nucleic Acid Amplification, Influenza Virus
- MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- JLBAtp And Creatine Kinase (Enzymatic), Creatine
- JIPBlood, Occult, Enzymatic Method, In Urine
- OZBDengue Nucleic Acid Amplification Assay (Naat)
- QCUDengue Virus Antigen Assay
- PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- DBFFerritin, Antigen, Antiserum, Control
- PPMGeneral Purpose Reagent
- LYRHelicobacter Pylori
- PDJHemoglobin A1c Test System
- LOLHepatitis A Test (Antibody And Igm Antibody)
- MMIImmunoassay Method, Troponin Subunit
- NSUInstrumentation For Clinical Multiplex Test Systems
- JSXKit, Identification, Neisseria Gonorrhoeae
- MJXKit, Serological, Positive Control
- OPMMultiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
- OAXPlasmodium Spp. Detection Reagents
- CDDRadioassay, Vitamin B12
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- LOOReagent, Leishmanii Serological
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- POAReagents, Zika Virus Nucleic Acid
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DCNSystem, Test, C-Reactive Protein
- DHASystem, Test, Human Chorionic Gonadotropin
- DHRSystem, Test, Rheumatoid Factor
- MRGSystem, Test, Vitamin D
- LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- MZFTest, Hiv Detection
- NBCTest, Natriuretic Peptide
- NWYTest, Qualitative, Detection Of Dengue Igm And Igg Antibodies
- MTNTest, Syphilis, Treponemal
- JHIVisual, Pregnancy Hcg, Prescription Use
- PYSZika Virus Serological Reagents (Emergency Use)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets CTK Biotech, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain