10 results
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29ms
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Sources: EU EUDAMED, US FDA
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FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
FDA Recall
Terminated
·Qualigen Inc·Product code CEC·November 8, 2013
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.
FDA Recall
Terminated
·Qualigen Inc·Product code LTJ·November 8, 2013
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
FDA Recall
Terminated
·Qualigen Inc·Product code CDZ·November 8, 2013
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.
FDA Recall
Terminated
·Qualigen Inc·Product code MRG·November 8, 2013
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.
FDA Recall
Open, Classified
·Qualigen Inc·Product code CDZ·December 3, 2024
Device to determine quantitative total testosterone in human serum
FDA Recall
Terminated
·Qualigen Inc·Product code CDZ·September 19, 2003
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
FDA Recall
Terminated
·Qualigen Inc·Product code MRG·July 7, 2017
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 Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
FDA Recall
Terminated
·Qualigen Inc·Product code CDZ·November 6, 2019
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
FDA Recall
Open, Classified
·Qualigen Inc·Product code JLW·August 26, 2024
FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
FDA Recall
Terminated
·Qualigen Inc·Product code LTJ·September 29, 2008