FDA Registration
Active
🇺🇸 United States
Aridia Influenza A/B & RSV Real-Time PCR Test (REF# P0187H/L)
Reg #: 2032682
·
FEI: 3003952975
·
Expires 2025
Products
1
Proprietary Names
173
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CTK BIOTECH, INC.
- Registration Number
- 2032682
- FEI Number
- 3003952975
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2021-10-05 |
Proprietary Names
Aridia Influenza A/B & RSV Real-Time PCR Test (REF# P0187H/L)
RapidLight Total Vitamin D CLIA Test (REF# L8010)
RaFIA Cys-C FIA Test (REF# F2021)
RapidLight CK-MB CLIA Test (REF# L3020)
OnSite Rota/Adeno Ag Rapid Test (REF# R0196C)
OnSite COVID-19 Ag Self Test (Ref# R0182CST)
OnSite Toxo IgG/IgM Combo Rapid Test (REF# R0234C)
RaFIA CRP FIA Test (REF# F0410)
OnSite Dengue IgG/IgM Combo Rapid Test (REF# R0061C)
OnSite HSV-1 IgG/IgM Rapid Test (REF# R0203C)
RaFIA NT-proBNP FIA Test (REF# F3050)
OnSite Dengue Ag Rapid Test (REF# R0063C)
OnSite Toxo IgG/IgM Rapid Test (REF# R0233C)
RecombiLISA HEV IgM ELISA (REF# E0105)
OnSite Syphilis Ab Rapid Test (REF# R0030C)
RecombiLISA HAV IgM ELISA (REF# E0100)
OnSite HSV-2 IgG/IgM Rapid Test (REF# R0213C)
OnSite Malaria Pf Ag Rapid Test (REF# R0114C)
OnSite Leishmania Ab Rapid Test (REF# R0122S)
Aridia Zika Virus Real-Time PCR Test (REF# P0070H/L)
OnSite HIV Ag/Ab 4th Gen Rapid Test (REF# R0018C)
RecombiLISA HBc IgM ELISA (REF# E0811)
RapidLight PRL CLIA Test (REF# L1080)
OnSite Syphilis Ab Combo Rapid Test (REF# R0031C)
RaFIA PCT FIA Test (REF# F0400)
RecombiLISA TSH ELISA (REF# E1030)
RapidLight free T4 CLIA Test (REF# L1026)
OnSite Leptospira IgG/IgM Combo Rapid Test (REF# R0101C)
RecombiLISA Chagas IgG ELISA (REF# E0170)
OnSite Cholera Ag Rapid Test (REF# R0130C)
RecombiLISA HBeAg ELISA (REF# E0720)
RaFIA COVID-19 Ag FIA Test (REF# F0182)
RaFIA D-Dimer FIA Test (REF# F3010)
OnSite hCG Urine Rapid Test (REF# R1000C)
OnSite Filarisis IgG/IgM Combo Rapid Test (REF# R0151C)
RapidLight AMH CLIA Test (REF# L1240)
RapidLight TSH CLIA Test (REF# L1030)
RapidLight beta-hCG CLIA Test (REF# L1000)
RecombiLISA Toxo IgM ELISA (REF# E0230)
RecombiLISA Dengue IgG ELISA (REF# E0311)
RapidLight Myoglobin CLIA Test (REF# L3030)
RaFIA MYO FIA Test (REF# F3030)
RecombiLISA HCV Ab ELISA (REF# E0511)
OnSite Chikungunya IgM Combo Rapid Test (REF# R0066C)
RecombiLISA HBsAg ELISA (REF# E0710)
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)
RaFIA Total Vitamin D FIA (REF# F8010)
RecombiLISA HIV 1+2 Ab ELISA (REF# E0410)
OnSite TORCH Panel Rapid Test (REF#R0253C)
OnSite HIV/Syphilis/HBV/HCV Panel Rapid Test (REF# R0038C)
OnSite RSV Ag Rapid Test (REF# R0186C)
OnSite PSA Semi-quantitative Rapid Test (REF# R2002C)
RapidLight D-Dimer CLIA Test (REF# L3010)
OnSite Troponin I Rapid Test (REF# R3001C)
OnSite Influenza A/B Ag Rapid Test (REF# R0187C)
OnSite FOB Hi Rapid Test (REF# R2011C)
Aridia Total Nucleic Acid Isolation Kit (REF# IK010)
RaFIA Total IgE FIA Test (Ref# F5020)
OnSite H. Pylori Ab Combo Rapid Test (REF# R0191C)
RapidLight cTnI CLIA Test (REF# L3002)
OnSite FOB Rapid Test (REF# R2010C)
RecombiLISA Syphilis Ab ELISA (REF# E0610)
OnSite Malaria Pf /Pv Ag Rapid Test (REF# R0112C)
OnSite Influenza A/B Rapid Test with Positivia External Controls (Ref# R0181S)
RaFIA T3 FIA Test (REF# F1015)
OnSite HBsAg Combo Rapid Test (REF# R0042C-CE)
RecombiLISA Dengue Ag ELISA (REF# E0312)
RapidLight Folate CLIA Test (REF# L8020)
RecombiLISA HBsAb ELISA (REF# E0711)
OnSite HIV 1/2 Ab Plus Combo Rapid Test (REF# R0011C)
RecombiLISA Leptospira IgM ELISA (REF#E0330)
OnSite HIV 1/2 Ab Plus Combo Rapid Test (REF# R0011C-CE)
RecombiLISA HBcAb ELISA (REF# E0810)
OnSite Syphilis Ab Rapid Test (REF# R0030S)
RecombiLISA CHIK IgM ELISA (REF# E0315)
RaFIA CK-MB FIA Test (REF# F3020)
RecombiLISA Zika IgM ELISA (REF# E0320)
RapidLight PCT CLIA Test (REF# L0400)
Aridia Chikungunya Virus Real-Time PCR Test (REF# P0066H/L)
OnSite Typhoid IgG/IgM Rapid Test (REF# R0160C)
OnSite Duo Dengue Ag - IgG/IgM Rapid Test (REF# R0062C)
OnSite Rotavirus Ag Rapid Test (REF# R0194C)
RecombiLISA Leishmania Ab ELISA (REF# E0121)
OnSite HBsAg Rapid Test (REF# R0040C)
OnSite Chagas Ab Combo Rapid Test (REF# R0171C)
OnSite HCV Ab Plus Combo Rapid Test (REF# R0024C-CE)
Aridia Zika/Dengue/CHIK Real-Time PCR Test (REF# P0071H/L)
OnSite Malaria Pf/Pv Ab Combo Rapid Test (REF# R0111C)
OnSite RF Rapid Test (REF# R0310C)
OnSite Duo Dengue IgG/IgM-CHIK IgM Rapid Test (REF# R0069C)
OnSite Strep A Rapid Test (REF# R0184S)
RaFIA Progesterone FIA Test (REF#F1220)
RecombiLISA Toxo IgG ELISA (REF# E0231)
Aridia Dengue Serotyping Real-Time PCR Test (REF# P0061H/L)
OnSite hCG Combo Rapid Test (REF# R1001S)
RecombiLISA HBeAb ELISA (REF# E0721)
RaFIA PRL FIA Test (REF#F1080)
OnSite Typhoid IgG/IgM Combo Rapid Test (REF# R0161C)
Aridia Dengue Virus Real-Time PCR Test (REF# P0060H/L)
Aridia Influenza A Typing Real-Time PCR Test (REF# P0188H/L)
RaFIA Testosterone FIA Test (REF#F1210)
RapidLight Total T4 CLIA Test (REF# L1025)
RapidLight free T3 CLIA Test (REF# L1016)
RaFIA AMH FIA Test (REF# F1240)
RaFIA Estradiol FIA Test (REF# F1230)
RaFIA T4 FIA Test (REF# F1025)
Aridia HPV 16/18 Real-Time PCR Test (REF# P0036H/L)
RaFIA fPSA FIA Test (REF# F2004)
OnSite Leishmania IgG/IgM Combo Rapid Test (REF# R0121C)
Aridia HSV1/HSV2/T. pallidum Real-Time PCR Test (REF# P0218H/L)
OnSite Chlamydia Ag Rapid Test (REF# R0080C)
RaFIA MAU FIA Test (REF# F2020)
RecombiLISA Total T3 ELISA (REF# E1010)
RecombiLISA Total T4 ELISA (REF# E1020)
RapidLight hs-cTnI CLIA Test (REF# L3003)
RaFIA TSH FIA Test (REF# F1030)
OnSite Rubella IgG/IgM Rapid Test (REF# R0243C)
RapidLight Total T3 CLIA Test (REF# L1015)
OnSite HEV IgM Rapid Test (REF# R0095C)
RaFIA AFP FIA Test (REF# F2030)
RapidLight Vitamin B12 CLIA Test (REF# L8030)
OnSite HAV IgG/IgM Rapid Test (REF# R0092C)
OnSite Influenza A/B Rapid Test (REF# R0187S)
OnSite HIV/Syphilis Ab Combo Rapid Test (REF# R0035C)
RapidLight LH CLIA Test (REF# L1090)
OnSite CMV IgG/IgM Rapid Test (REF# R0224C)
OnSite HCV Ab Plus Combo Rapid Test (REF# R0024C)
RapidLight Ferritin CLIA Test (REF# L5010)
OnSite HBsAg Rapid Test (REF# R0040S)
OnSite Duo HSV-1/2 IgG/IgM Rapid Test (REF# R0218C)
OnSite HBsAg Combo Rapid Test (REF# R0042C)
RaFIA tPSA FIA Test (REF# F2003)
RaFIA FSH FIA Test (REF#F1100)
RapidLight Progesterone CLIA Test (REF# L1220)
RaFIA LH FIA Test (REF#F1090)
Aridia T. pallidum Real-Time PCR Test (REF# P0030H/L)
OnSite S. Typhi/Paratyphi Ag Rapid Test (REF# R0162C)
OnSite HAV IgM Rapid Test (REF# R0090C)
RapidLight Testosterone CLIA Test (REF# L1210)
OnSite Dengue IgG Rapid Test (REF# R0065C)
RecombiLISA Free T3 ELISA (REF#E1011)
RapidLight NT-proBNP CLIA Test (REF# L3050)
OnSite hCG Combo Rapid Test (REF# R1001C)
OnSite hCG Urine Rapid Test (REF# R1000S)
OnSite HBV-5 Rapid Test (REF# R0049C)
RecombiLISA Free T4 ELISA (REF# E1021)
RecombiLISA HIV 1+2 Ag-Ab ELISA (REF# E0420)
RecombiLISA HCV IgG ELISA (REF# E0510)
OnSite Toxo IgG/IgM Rapid Test (REF# R0233S)
Aridia West Nile Virus Real-Time PCR Test (REF# P0148H/L)
RaFIA CEA FIA Test (REF# F2015)
OnSite HCV Ab Plus Rapid Test (REF# R0023C)
RaFIA cTnI FIA Test (REF# F3002)
RaFIA HbA1c FIA Test (REF# F6100)
OnSite Strep A Rapid Test (REF# R0184C)
OnSite Troponin I Combo Rapid Test (REF# R3002C)
RaFIA beta-hCG FIA Test (REF# F1000)
RapidLight E2 CLIA Test (REF# L1230)
RecombiLISA Dengue IgM ELISA (REF# E0310)
OnSite HCV Ab Plus Rapid Test (REF# R0023S)
OnSite H. Pylori Ag Rapid Test (REF# R0192C)
Aridia Rhinovirus/Enterovirus Real-Time PCR Test (REF# P0182H/L)
OnSite COVID-19 + Influenza A/B Ag Rapid Test (REF# R0188C)
RaFIA Ferritin FIA Test (Ref# F5010)
Aridia COVID-19 Real-Time PCR Test (REF# P0180)
RapidLight FSH CLIA Test (REF# L1100)
OnSite COVID-19 Ag Rapid Test (Ref# R0182C)
OnSite Malaria Pf / Pan Ag Rapid Test (REF# R0113C)
OnSite Adenovirus Ag Rapid Test (REF# R0189C)
OnSite HBsAg/HCV Ab Rapid Test (REF# R0028C)
OnSite Duo CMV IgG-IgM Rapid Test (REF# R0223C)
Establishment Types
Manufacture Medical Device