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Sign in to claim this brandQUALIGEN INC.
US
Last updated May 24, 2026
What QUALIGEN INC. makes
Qualigen Inc. manufactures in vitro diagnostic (IVD) kits and analyzers for chemiluminescent immunoassays. These products include tests for total prostate-specific antigen (tPSA), total testosterone, total human chorionic gonadotropin (hCG), sex hormone binding globulin (SHBG), and 25-hydroxy vitamin D. The company also produces controls and calibrators for these assays.
The company's portfolio is regulated under U.S. federal law, with devices listed in the FDA's 510(k) database and the Unique Device Identification (UDI) registry. Qualigen Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- qualigeninc.com
- —
- —
- [email protected]
- Phone
- 1-877-770-6127
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 959103565
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FastPack® IP Total PSA Kit (30) | TPSA Immunoassay | FDA UDI | Class II | Active |
| FastPack® IP hCG Diluent Kit (25) | hCG Diluent | FDA UDI | Class II | Active |
| FastPack® IP SHBG | FastPack® IP SHBG 30 Immunoassay | FDA UDI | Class I | Active |
| FastPack SARS-CoV-2 IgG | SARS-CoV-2 IgG Immunoassay | FDA UDI | N | Active |
| FastPack® IP System | IP System | FDA UDI | Class I | Active |
| FastPack® IP System | IP System | FDA UDI | Class I | Active |
| FastPack® IP System | IP System | FDA UDI | Class I | Active |
| Calibrator Kit – Free T4 | FT4 Cal | FDA UDI | Class II | Active |
| FastPack® IP SHBG | FastPack® IP SHBG 60 Immunoassay | FDA UDI | Class I | Active |
| Calibrator Kit – TSH | TSH Cal | FDA UDI | Class II | Active |
| FastPack® Testo Kit (50) | Testo Immunoassay | FDA UDI | Class I | Active |
| FastPack® IP Testo Kit (30) | Testo Immunoassay | FDA UDI | Class I | Active |
| FastPack® Total PSA Kit (50) | TPSA Immunoassay | FDA UDI | Class II | Active |
| FastPack® IP Testo Kit (90) | Testo Immunoassay | FDA UDI | Class I | Active |
| FastPack® Control Kit | Multi-Analyte Controls | FDA UDI | Class I | Active |
| Control Kit - PSA | PSA Controls | FDA UDI | Class I | Active |
| FastPack® IP hCG Kit (30) | hCG Immunoassay | FDA UDI | Class II | Active |
| FastPack® IP TSH Kit (30) | TSH Immunoassay | FDA UDI | Class II | Active |
| Calibrator Kit – hCG | hCG Cal | FDA UDI | Class II | Active |
| Calibrator Kit - Testosterone | Testo Cal | FDA UDI | Class II | Active |
| Calibrator Kit - PSA | TPSA Cal | FDA UDI | Class II | Active |
| FastPack® IP System | IP System | FDA UDI | Class I | Active |
| FastPack® IP Vitamin D Kit Complete | Vit. D Immunoassay | FDA UDI | Class II | Active |
| FastPack® IP Free T4 Kit (30) | FT4 Immunoassay | FDA UDI | Class II | Active |
| FastPack® IP Total PSA Kit (90) | TPSA Immunoassay | FDA UDI | Class II | Active |
| Method Verification Kit - PSA | TPSA Verifier | FDA UDI | Class I | Active |
| FastPack® Pro System | Pro System | FDA UDI | Class I | Active |
| Method Verification Kit - Vitamin D | Vit. D Verifier | FDA UDI | Class I | Active |
| 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 | K141689 | FDA 510(k) | Class II | Active |
| Fastpack Testosterone Calibrator | K022533 | FDA 510(k) | Class II | Active |
| Fastpack Psa Immunoassay, Fastpack Analyzer | K003094 | FDA 510(k) | Class II | Active |
| Fastpack Free T4 Immunoassay | K030329 | FDA 510(k) | Class II | Active |
| Fastpack Testo Immunoassay | K101388 | FDA 510(k) | Class I | Active |
| Fastpack Control | K003095 | FDA 510(k) | Class I | Active |
| Fastpack Total Psa Method Verification Kit | K062957 | FDA 510(k) | Class I | Active |
| Fastpack Total Testosterone Immunoassay | K021972 | FDA 510(k) | Class I | Active |
| Fastpack Tsh Immunoassay | K052301 | FDA 510(k) | Class II | Active |
| Fastpack Calibrators | K003096 | FDA 510(k) | Class II | Active |
| Fastpack Control Kit | K123725 | FDA 510(k) | Class I | Active |
| Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers | K123983 | FDA 510(k) | Class II | Active |
| Fastpack Tsh Immunoassay | K101390 | FDA 510(k) | Class II | Active |
| Fastpack Hcg Immunoassay | K072264 | FDA 510(k) | Class II | Active |
| FastPack IP Sex Hormone Binding Globulin Immunoassay | K182521 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
There are 10 recall records for Qualigen Inc., with the earliest initiated on 2003-09-19 and the most recent on 2024-12-03. The statuses of these recalls include open, classified, and terminated. The reasons given for the recalls include incorrect barcodes on TSH calibrator cards, manufacturing defects in FastPack kits causing lower than expected results, higher than expected results in chemiluminescent immunoassay affecting Sex Hormone Binding Globulin determinations, falsely elevated results from certain kits, falsely lower than expected results for Vitamin D in specific lots, incorrect expiration dates on three lots of FastPack SHBG Complete Kits (lot numbers 2408018-1, 2409015-1, and 2409015-2), and a recall initiated after investigation of customer complaints regarding falsely elevated results and product performance expectations.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 3, 2024 | Z-0805-2025 | — | open, classified | Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age. |
| Aug 26, 2024 | Z-0022-2025 | — | open, classified | Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected. |
| Nov 6, 2019 | Z-1672-2020 | — | terminated | The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma. |
| Jul 7, 2017 | Z-3112-2017 | — | terminated | Specific lots have been reported to produce falsely lower than expected results for Vitamin D |
| Nov 8, 2013 | Z-0550-2014 | — | terminated | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| Nov 8, 2013 | Z-0547-2014 | — | terminated | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| Nov 8, 2013 | Z-0549-2014 | — | terminated | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| Nov 8, 2013 | Z-0548-2014 | — | terminated | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| Sep 29, 2008 | Z-0500-2009 | — | terminated | The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations. |
| Sep 19, 2003 | Z-0090-04 | — | terminated | Kits may produce results that are falsely elevated. |