Qualigen, Inc.
Medical device manufacturer in Carlsbad, CA.
15510(k) clearances
0PMA approvals
9recalls
Device types
- CDZ Radioimmunoassay, Testosterones And… 3
- JJX Single (Specified) Analyte Controls… 2
- JIT Calibrator, Secondary 2
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- LTJ Prostate-Specific Antigen (Psa) For… 1
- CEC Radioimmunoassay, Free Thyroxine 1
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- MRG System, Test, Vitamin D 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional | 01/29/2019SE |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | 01/07/2015SE |
| K123983 | Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersMRG · Traditional | 07/03/2013SE |
| K123725 | Fastpack Control KitJJY · Traditional | 03/08/2013SE |
| K101388 | Fastpack Testo ImmunoassayCDZ · Special | 02/18/2011SE |
| K101390 | Fastpack TSH ImmunoassayJLW · Special | 08/13/2010SE |
| K072264 | Fastpack HCG ImmunoassayJHI · Traditional | 12/06/2007SE |
| K062957 | Fastpack Total Psa Method Verification KitJJX · Abbreviated | 04/02/2007SE |
| K052301 | Fastpack TSH ImmunoassayJLW · Traditional | 01/04/2006SE |
| K030329 | Fastpack Free T4 ImmunoassayCEC · Traditional | 07/03/2003SE |
| K022533 | Fastpack Testosterone CalibratorJIT · Abbreviated | 09/30/2002SE |
| K021972 | Fastpack Total Testosterone ImmunoassayCDZ · Traditional | 08/21/2002SE |
| K003096 | Fastpack CalibratorsJIT · Abbreviated | 11/30/2000SE |
| K003095 | Fastpack ControlJJX · Abbreviated | 11/29/2000SE |
| K003094 | Fastpack Psa Immunoassay, Fastpack AnalyzerLTJ · Special | 10/25/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0805-2025 Class III | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the…Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect… | 12/03/2024Open, Classified |
| Z-0022-2025 Class II | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP…Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information… | 08/26/2024Open, Classified |
| Z-1672-2020 Class II | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement…The chemiluminescent immunoassay has been noted to have higher than expected results which may result in… | 11/06/2019Terminated |
| Z-3112-2017 Class II | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number…Specific lots have been reported to produce falsely lower than expected results for Vitamin D | 07/07/2017Terminated |
| Z-0550-2014 Class II | FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for…Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a… | 11/08/2013Terminated |
| Z-0549-2014 Class II | FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The…Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a… | 11/08/2013Terminated |
| Z-0548-2014 Class II | FastPack Testosterone Immunoassay Chemilunescence assay for the determination of…Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a… | 11/08/2013Terminated |
| Z-0547-2014 Class II | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA.…Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a… | 11/08/2013Terminated |
| Z-0500-2009 | FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle…The recall was initiated after the firm investigation of customer complaints of falsely elevated results… | 09/29/2008Terminated |