Qualigen Inc
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 15
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0805-2025 | Class III | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative me | December 3, 2024 |
| Z-0022-2025 | Class II | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoas | August 26, 2024 |
| Z-1672-2020 | Class II | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG | November 6, 2019 |
| Z-3112-2017 | Class II | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitami | July 7, 2017 |
| Z-0550-2014 | Class II | FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determ | November 8, 2013 |
| Z-0547-2014 | Class II | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPa | November 8, 2013 |
| Z-0548-2014 | Class II | FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone T | November 8, 2013 |
| Z-0549-2014 | Class II | FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastP | November 8, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | January 29, 2019 |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibr | January 7, 2015 |
| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | July 3, 2013 |
| K123725 | FASTPACK CONTROL KIT | March 8, 2013 |
| K101388 | FASTPACK TESTO IMMUNOASSAY | February 18, 2011 |
| K101390 | FASTPACK TSH IMMUNOASSAY | August 13, 2010 |
| K072264 | FASTPACK HCG IMMUNOASSAY | December 6, 2007 |
| K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | April 2, 2007 |
| K052301 | FASTPACK TSH IMMUNOASSAY | January 4, 2006 |
| K030329 | FASTPACK FREE T4 IMMUNOASSAY | July 3, 2003 |
| K022533 | FASTPACK TESTOSTERONE CALIBRATOR | September 30, 2002 |
| K021972 | FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY | August 21, 2002 |
| K003096 | FASTPACK CALIBRATORS | November 30, 2000 |
| K003095 | FASTPACK CONTROL | November 29, 2000 |
| K003094 | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | October 25, 2000 |