Qualigen, Inc.
Qualigen, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2019, with 8 FDA device recalls on record.
Top product codes for Qualigen, Inc.
FDA recalls by Qualigen, Inc.
- Z-0805-2025 — 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.
- Z-0022-2025 — FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- Z-1672-2020 — 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
- Z-3112-2017 — Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
- Z-0550-2014 — 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.
- Z-0547-2014 — 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.
- Z-0549-2014 — 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.
- Z-0548-2014 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Qualigen, Inc.
- K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay
- K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
- K123983 — FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
- K123725 — FASTPACK CONTROL KIT
- K101388 — FASTPACK TESTO IMMUNOASSAY
- K101390 — FASTPACK TSH IMMUNOASSAY
- K072264 — FASTPACK HCG IMMUNOASSAY
- K062957 — FASTPACK TOTAL PSA METHOD VERIFICATION KIT
- K052301 — FASTPACK TSH IMMUNOASSAY
- K030329 — FASTPACK FREE T4 IMMUNOASSAY
- K022533 — FASTPACK TESTOSTERONE CALIBRATOR
- K021972 — FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
- K003096 — FASTPACK CALIBRATORS
- K003095 — FASTPACK CONTROL
- K003094 — FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.