CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone Class I
FDA Device Classification
Classification Details
- Product Code
- CDZ
- Device Class
- Class I
- Regulation Number
- 862.1680
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K240865 | immunodiagnostic systems limited | IDS-iSYS Free Testosterone | October 23, 2024 |
| K233480 | beckman coulter | Access SHBG | February 8, 2024 |
| K223405 | beckman coulter | Access Testosterone | January 13, 2023 |
| K211685 | roche diagnostics | Elecsys Testosterone II | May 6, 2022 |
| K201908 | diasorin | LIAISON Testosterone xt | October 15, 2020 |
| K191350 | immunotech s.r.o | ACTIVE® Free Testosterone RIA | December 20, 2019 |
| K191533 | siemens healthcare diagnostics | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | August 28, 2019 |
| K190121 | immunodiagnostic systems | IDS SHBG | June 17, 2019 |
| K182521 | qualigen | FastPack IP Sex Hormone Binding Globulin Immunoassay | January 29, 2019 |
| K181017 | monobind | Free Testosterone AccuBind ELISA Test System | July 20, 2018 |
| K153577 | nanoentek usa | FREND Testosterone Test System | October 14, 2016 |
| K151986 | siemens healthcare diagnostics | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Maste | June 29, 2016 |
| K151529 | siemens healthcare diagnostics | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista | February 11, 2016 |
| K152185 | biokit | ARCHITECT SHBG | February 11, 2016 |
| K152155 | abbott laboratories | ARCHITECT 2nd Generation Testosterone | December 17, 2015 |
| K143075 | tosoh bioscience | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | July 2, 2015 |
| K133491 | siemens healthcare diagnostics | ADVIA CENTAUR TESTOSTERONE (TSTO) | February 21, 2014 |
| K122793 | diasorin | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | January 25, 2013 |
| K120009 | abbott laboratories | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND | September 11, 2012 |
| K101388 | qualigen | FASTPACK TESTO IMMUNOASSAY | February 18, 2011 |