QUALIGEN, INC.

FDA Device Registration & Listing · CARLSBAD, CA, US · Registration 2032087

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2032087
FEI Number
3003355251
Entity Name
QUALIGEN, INC.
City/State/Country
CARLSBAD, CA, US
Establishment Address
2042 CORTE DEL NOGAL, CARLSBAD, CA 92011, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
QUALIGEN, INC. (Owner Number: 9040045)
Owner / Operator Contact Address
2042 CORTE DEL NOGAL, --, Carlsbad, CA 92011, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K003095
PMA Number
N/A

All Registered Proprietary Names

FastPack TPSA Calibrator FastPack® IP SHBG FastPack® IP Vitamin D Kit FAST PACK TSH IMMUNOASSAY FastPack Testo Immunoassay FastPack Free T4 Immunoassay FAST PACK (TM) ANALYZER SYSTEM FastPack Testo Calibrator FastPack hCG Immunoassay FastPack PSA Controls

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-08-30
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2019-02-26
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2013-12-17
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-12-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-12-17
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2006-04-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2006-04-03
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2006-04-03
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2016-08-30
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2007-10-09
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2007-10-09
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2000-05-18
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-08-30
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-01-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-01-31
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-08-30

Official Correspondent

Scott Doyle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QUALIGEN, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21
K081789 Siemens Healthcare Diagnostics, Inc. DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR 2008-09-10
K103836 Siemens Healthcare Diagnostics, Inc. ENZYME II CALIBRATOR 2011-02-16
K103548 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 2011-06-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2025 Qualigen Inc 2
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032087. Last updated year: 2026. Please use registration number 2032087 when referencing this establishment in official correspondence.
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