Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032682

FEI Number

3003952975

Entity Name

CTK BIOTECH, INC.

City/State/Country

Poway, CA, US

Establishment Address

13855 Stowe Dr, Poway, CA 92064, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

CTK BIOTECH, INC. (Owner Number: 9051784)

Owner / Operator Contact Address

13855 Stowe Dr., --, Poway, CA 92064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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) RapidLight Total T3 CLIA Test (REF# L1015) 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 Total T3 ELISA (REF# E1010) 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) RaFIA T3 FIA Test (REF# F1015) 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) OnSite COVID-19 IgG/IgM Rapid Test (REF# R0180C) RaFIA Progesterone FIA Test (REF#F1220) CTK Progesterone ELISA (REF# E1220) RapidLight Progesterone CLIA Test (REF# L1220) OnSite Cholera Ag Rapid Test (REF# R0130C) RaFIA CK-MB FIA Test (REF# F3020) RapidLight CK-MB CLIA Test (REF# L3020) OnSite Rubella IgG/IgM Rapid Test (REF# R0243C) RapidLight Vitamin B12 CLIA Test (REF# L8030) CTK Testosterone ELISA (REF# E1210) RecombiLISA Leptospira IgM ELISA (REF#E0330) OnSite Leptospira IgG/IgM Combo Rapid Test (REF# R0101C) OnSite Adenovirus Ag Rapid Test (REF# R0189C) OnSite Rota/Adeno Ag Rapid Test (REF# R0196C) OnSite hCG Combo Rapid Test (REF# R1001S) OnSite hCG Urine Rapid Test (REF# R1000C) OnSite hCG Combo Rapid Test (REF# R1001C) RaFIA beta-hCG FIA Test (REF# F1000) OnSite hCG Urine Rapid Test (REF# R1000S) RapidLight beta-hCG CLIA Test (REF# L1000) Aria Strep A Rapid Test OnSite Strep A Rapid Test RaFIA T4 FIA Test (REF# F1025) RapidLight Total T4 CLIA Test (REF# L1025) RecombiLISA Total T4 ELISA (REF# E1020) RaFIA tPSA FIA Test (REF# F2003) OnSite PSA Semi-quantitative Rapid Test (REF# R2002C) RaFIA fPSA FIA Test (REF# F2004) RecombiLISA Zika IgM ELISA (REF# E0320) RaFIA Ferritin FIA Test (Ref# F5010) RapidLight Ferritin CLIA Test (REF# L5010) OnSite Rotavirus Ag Rapid Test (REF# R0194C) RaFIA CRP FIA Test (REF# F0410) OnSite Gonorrhea Rapid Test RaFIA HbA1c FIA Test (REF# F6100) CTK PRL ELISA (REF# E1080) OnSite Leishmania IgG/IgM Combo Rapid Test (REF# R0121C) RecombiLISA Leishmania Ab ELISA (REF# E0121) OnSite Leishmania Ab Rapid Test (REF# R0122S) OnSite HBsAg/HCV Ab Rapid Test (REF# R0028C) RecombiLISA HBc IgM ELISA (REF# E0811) OnSite HBsAg Rapid Test (REF# R0040S) RecombiLISA HBeAg ELISA (REF# E0720) OnSite HBV-5 Rapid Test (REF# R0049C) RecombiLISA HBsAb ELISA (REF# E0711) OnSite HBsAg Rapid Test (REF# R0040C) OnSite HBsAg Combo Rapid Test (REF# R0042C) RecombiLISA HBeAb ELISA (REF# E0721) RecombiLISA HBsAg ELISA (REF# E0710) OnSite HBsAg Combo Rapid Test (REF# R0042C-CE) RecombiLISA HBcAb ELISA (REF# E0810) OnSite Syphilis Ab Rapid Test (REF# R0030C) OnSite Syphilis Ab Rapid Test (REF# R0030S) RecombiLISA Syphilis Ab ELISA (REF# E0610) OnSite Syphilis Ab Combo Rapid Test (REF# R0031C) OnSite RSV Ag Rapid Test (REF# R0186C) OnSite Duo CMV IgG-IgM Rapid Test (REF# R0223C) OnSite CMV IgG/IgM Rapid Test (REF# R0224C) OnSite Toxo IgG/IgM Combo Rapid Test (REF# R0234C) RecombiLISA Toxo IgM ELISA (REF# E0230) RecombiLISA Toxo IgG ELISA (REF# E0231) OnSite Toxo IgG/IgM Rapid Test (REF# R0233S) OnSite Toxo IgG/IgM Rapid Test (REF# R0233C) RapidLight PCT CLIA Test (REF# L0400) RaFIA PCT FIA Test (REF# F0400) RecombiLISA Chagas IgG ELISA (REF# E0170) OnSite Chagas Ab Combo Rapid Test (REF# R0171C) Aridia Dengue Virus Real-Time PCR Test (REF# P0060H/L) Aridia Dengue Serotyping Real-Time PCR Test (REF# P0061H/L) OnSite TORCH Panel Rapid Test (REF#R0253C) Aridia Zika/Dengue/CHIK Real-Time PCR Test (REF# P0071H/L) Aridia Zika Virus Real-Time PCR Test (REF# P0070H/L) OnSite H. Pylori Ab Combo Rapid Test (REF# R0191C) OnSite H. Pylori Ag Rapid Test (REF# R0192C) OnSite H. Pylori Ag Rapid Test (REF# R0192S) OnSite HCV Ab Plus Rapid Test (REF# R0023C) OnSite HCV Ab Plus Rapid Test (REF# R0023S) OnSite HCV Ab Plus Combo Rapid Test (REF# R0024C) RecombiLISA HCV IgG ELISA (REF# E0510) RecombiLISA HCV Ab ELISA (REF# E0511) CTK Estradiol (E2) ELISA (REF# E1230) RecombiLISA TSH ELISA (REF# E1030) RapidLight TSH CLIA Test (REF# L1030) RaFIA TSH FIA Test (REF# F1030) OnSite FOB Rapid Test (REF# R2010C) OnSite FOB Hi Rapid Test (REF# R2011C) ImmuView COVID-19 Antigen Home Test (REF# R0182CHT) OnSite Dengue IgG/IgM Combo Rapid Test (REF# R0061C) RecombiLISA Dengue IgG ELISA (REF# E0311) OnSite Duo Dengue IgG/IgM-CHIK IgM Rapid Test (REF# R0069C) RecombiLISA Dengue IgM ELISA (REF# E0310) OnSite Dengue IgG Rapid Test (REF# R0065C) OnSite Duo Dengue Ag - IgG/IgM Rapid Test (REF# R0062C) OnSite Malaria Pf / Pan Ag Rapid Test (REF# R0113C) OnSite Malaria Pf/Pv Ab Combo Rapid Test (REF# R0111C) OnSite Malaria Pf Ag Rapid Test (REF# R0114C) OnSite Malaria Pf /Pv Ag Rapid Test (REF# R0112C) OnSite HAV IgG/IgM Rapid Test (REF# R0092C) RecombiLISA HAV IgM ELISA (REF# E0100) OnSite HAV IgM Rapid Test (REF# R0090C) RecombiLISA Dengue Ag ELISA (REF# E0312) OnSite Dengue Ag Rapid Test (REF# R0063C) OnSite Duo Dengue Ag - IgG/IgM Rapid Test (REF# R0062C)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2018-10-04
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2002-06-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2021-10-05
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-25
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2018-10-04
GSQ	Antiserum, Vibrio Cholerae, All Varieties	Microbiology	Class 2	866.3930	2019-07-16
JLB	Atp And Creatine Kinase (Enzymatic), Creatine	Clinical Chemistry	Class 1	862.1210	2020-08-20
GOM	Antisera, Cf, Rubella	Microbiology	Class 2	866.3510	2018-09-26
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2018-10-04
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2018-10-04
GRX	Antisera, All Leptospira Spp.	Microbiology	Class 2	866.3350	2018-09-26
GOA	Antisera, Cf, Adenovirus 1-33	Microbiology	Class 1	866.3020	2018-09-26
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2018-09-26
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2019-07-16
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2018-10-04
NAF	Antigen(Complexed),Prostate Specific,(Cpsa)	Unknown	Class 3	N/A	2018-09-27
PYS	Zika Virus Serological Reagents (Emergency Use)	Unknown	Class N	N/A	2018-10-04
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2020-08-20
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Microbiology	Class 1	866.3405	2018-09-26
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2020-08-20
JSX	Kit, Identification, Neisseria Gonorrhoeae	Microbiology	Class 1	866.2660	2018-09-26
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2020-08-20
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2018-10-04
LOO	Reagent, Leishmanii Serological	Microbiology	Class 1	866.3870	2018-09-26
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2018-09-26
MTN	Test, Syphilis, Treponemal	Unknown	Class N	N/A	2018-09-26
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2018-09-26
GQI	Antiserum, Cf, Cytomegalovirus	Microbiology	Class 2	866.3175	2018-09-26
LJK	Antisera, If, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2018-09-26
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2020-08-20
GND	Antigen, Iha, T. Cruzi	Microbiology	Class 1	866.3870	2018-09-26
OZB	Dengue Nucleic Acid Amplification Assay (Naat)	Microbiology	Class 2	866.3946	2018-10-04
OPM	Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2	Microbiology	Class 2	866.3510	2018-09-26
POA	Reagents, Zika Virus Nucleic Acid	Unknown	Class N	N/A	2018-10-04
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2018-09-26
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2018-09-26
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2018-10-04
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2018-10-04
JIP	Blood, Occult, Enzymatic Method, In Urine	Hematology	Class 2	864.6550	2018-10-04
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2022-03-11
NWY	Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies	Unknown	Class N	N/A	2018-09-26
OAX	Plasmodium Spp. Detection Reagents	Microbiology	Class 2	866.3402	2018-09-26
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2018-09-26
QCU	Dengue Virus Antigen Assay	Microbiology	Class 2	866.3945	2018-09-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CTK BIOTECH, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K931600	Nichols Institute	CHEMILUMINESCENCE FREE T3 IMMUNOASSAY	1993-09-08
K852537	Ria Diagnostics	T-3 RIASSAY	1985-08-12
K780018	Clinical Immuno-Diagnostics	THYRO-INDICATOR T-3 125I	1978-02-07
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0006-06	Nichols Institute Diagnostics	2	Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
Z-0007-06	Nichols Institute Diagnostics	2	Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
Z-0128-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
Z-0129-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)

Similar Registrations

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3004192065	SENSOR HEALTH PRODUCTS, INC.	CAMBRIDGE Ontario, CA
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032682. Last updated year: 2026. Please use registration number 2032682 when referencing this establishment in official correspondence.