Panels › Clinical Chemistry › Product code CDZ · Class 1
Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation 862.1680
1510(k)s in 12 months (89 all time)
2recalls in 12 months (19 all time)
17recalls that name a 510(k)
Top companies in CDZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2026 | Tosoh Bioscience Inc ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204 Open, Classified |
CDZ | K023091 |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Men s Hormone Test Open, Classified |
CDZ | None listed |
| Jun 2, 2025 | Beckman Coulter, Inc. Access Testosterone assay, Catalog Number 33560 Open, Classified |
CDZ | K223405 |
| Jan 3, 2025 | Qualigen Inc The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks. Open, Classified |
CDZ | K182521 |
| Aug 15, 2024 | DRG International, Inc. Product Name: Salivary Testosterone ELISA
Model/Catalog Number: SLV-3013
Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in Open, Classified |
CDZ | K052649 |
| Dec 2, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and hepariniz Open, Classified |
CDZ | K032881 |
| Nov 6, 2019 | Qualigen Inc The FastPack System Comlete Immunoassay Kit
Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding G Terminated |
CDZ | K182521 |
| May 21, 2019 | DRG Instruments GmbH DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva
Catalog # SLV-3013
Product Usage:
The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for th Terminated |
CDZ | K052649 |
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testo Terminated |
CDZ | K023091 |
| Mar 21, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586 Terminated |
CDZ | K151529 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Testosterone; Part Number: 025204
Assay, Reproductive Hormone Terminated |
CDZ | K023091 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK SHBG; Part Number: 025238
Assay, Reproductive Hormone Terminated |
CDZ | K143075 |
| Jun 29, 2017 | bioMerieux, Inc. VIDAS Testosterone, Ref 30418 Terminated |
CDZ | K021326 |
| May 3, 2017 | Abbott Laboratories ARCHITECT SHBG Reagent
The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and p Terminated |
CDZ | K060818 |
| Apr 19, 2017 | Siemens Healthcare Diagnostics, Inc. SHBG IMMULITE 2000/IMMULITE 2000 XPi
For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of Terminated |
CDZ | K955440 |
| Dec 19, 2013 | Qualigen Inc FastPack Testosterone Immunoassay
Chemilunescence assay for the determination of Testosterone
The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative dete Terminated |
CDZ | K021972 |
| Nov 22, 2010 | Beckman Coulter Inc. Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantit Terminated |
CDZ | K083867 |
| Feb 16, 2006 | Diagnostic Products Corp. IMMULITE 2000 Total Testosterone Kit Terminated |
CDZ | K032881 |
| Nov 6, 2003 | Qualigen Inc Device to determine quantitative total testosterone in human serum Terminated |
CDZ | None listed |
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