This page includes the latest FDA filings for Qualigen Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2032087 |
| FEI Number | 3003355251 |
| Name | QUALIGEN, INC. |
| Owner & Operator | QUALIGEN, INC. |
| Contact Address | 2042 CORTE DEL NOGAL -- Carlsbad CA 92011 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2042 CORTE DEL NOGAL CARLSBAD, CA 92011 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| QUALIGEN INC. | FastPack® IP hCG Kit (30) 25000044 | 2023-07-06 |
| QUALIGEN INC. | FastPack® Testo Kit (50) 25000009 | 2023-05-03 |
| QUALIGEN INC. | FastPack SARS-CoV-2 IgG 25000085 | 2020-08-13 |
| QUALIGEN INC. | FastPack® Pro System 08000067, 08000067-R, 08000067-X | 2020-08-13 |
| QUALIGEN INC. | FastPack® IP Total PSA Kit (90) 25000057 | 2020-02-06 |
| QUALIGEN INC. | FastPack® IP Total PSA Kit (30) 25000040 | 2020-02-06 |
| QUALIGEN INC. | FastPack® Total PSA Kit (50) 25000001 | 2020-02-06 |
| QUALIGEN INC. | Control Kit - PSA 25000003 | 2020-02-06 |
| QUALIGEN INC. | Method Verification Kit - PSA 25000017 | 2020-02-06 |
| QUALIGEN INC. | Calibrator Kit - PSA 25000002 | 2020-02-06 |
| QUALIGEN INC. | FastPack® IP SHBG 25000081 | 2019-03-25 |
QUALIGEN, INC. | FastPack? IP SHBG | 2019-02-26 |
Qualigen, Inc. | FastPack IP Sex Hormone Binding Globulin Immunoassay | 2019-01-29 |
QUALIGEN, INC. | Pipette Tips - IP | 2019-01-16 |
QUALIGEN, INC. | Pipette Fast Pack IP | 2019-01-16 |
QUALIGEN, INC. | FastPack IP 100ul Pipette | 2019-01-16 |
| QUALIGEN INC. | FastPack® IP Testo Kit (90) 25000058 | 2018-07-06 |
| QUALIGEN INC. | FastPack® IP TSH Kit (30) 25000042 | 2018-07-06 |
| QUALIGEN INC. | FastPack® IP Free T4 Kit (30) 25000043 | 2018-07-06 |
| QUALIGEN INC. | FastPack® IP Testo Kit (30) 25000041 | 2018-07-06 |
| QUALIGEN INC. | Method Verification Kit - Vitamin D 25000064, 25000074 | 2018-07-06 |
| QUALIGEN INC. | FastPack® Control Kit 25000056 | 2018-07-06 |
| QUALIGEN INC. | FastPack® IP hCG Diluent Kit (25) 25000036 | 2018-07-06 |
| QUALIGEN INC. | Calibrator Kit – hCG 25000035 | 2018-07-06 |
| QUALIGEN INC. | Calibrator Kit – TSH 25000024 | 2018-07-06 |
| QUALIGEN INC. | Calibrator Kit – Free T4 25000016 | 2018-07-06 |
| QUALIGEN INC. | Calibrator Kit - Testosterone 25000014 | 2018-07-06 |
| QUALIGEN INC. | FastPack® IP System 08000043-C, 08000043-CR | 2018-03-29 |
| QUALIGEN INC. | FastPack® IP System 08000043, 08000043-R, 08000043-X | 2018-03-29 |
QUALIGEN, INC. | FastPack TSH Immunoassay | 2016-08-30 |
QUALIGEN, INC. | FastPack Testo Immunoassay | 2016-08-30 |
QUALIGEN, INC. | FastPack PSA Verifier | 2016-08-30 |
QUALIGEN, INC. | FastPack Testo Calibrator | 2016-08-30 |
QUALIGEN, INC. | FastPack TPSA Calibrator | 2016-08-30 |
QUALIGEN, INC. | FastPack PSA Controls | 2016-08-30 |
QUALIGEN, INC. | FastPack TPSA Immunoassay | 2016-08-30 |
Qualigen, Inc. | 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 | 2015-01-07 |
QUALIGEN, INC. | FastPack? IP Vitamin D Kit | 2013-12-17 |
QUALIGEN, INC. | FastPack? IP Vitamin D Kit | 2013-12-17 |
QUALIGEN, INC. | FastPack? IP Vitamin D Kit | 2013-12-17 |
QUALIGEN, INC. | FastPack? Control Kit | 2013-12-17 |
Qualigen, Inc. | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | 2013-07-03 |
Qualigen, Inc. | FASTPACK CONTROL KIT | 2013-03-08 |
Qualigen, Inc. | FASTPACK TESTO IMMUNOASSAY | 2011-02-18 |
Qualigen, Inc. | FASTPACK TSH IMMUNOASSAY | 2010-08-13 |
QUALIGEN, INC. | FastPack hCG Immunoassay | 2008-01-31 |
QUALIGEN, INC. | FastPack hCG Immunoassay | 2008-01-31 |
Qualigen, Inc. | FASTPACK HCG IMMUNOASSAY | 2007-12-06 |
QUALIGEN, INC. | FastPack Free T4 Immunoassay | 2007-10-09 |
QUALIGEN, INC. | FastPack Free T4 Immunoassay | 2007-10-09 |
Qualigen, Inc. | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | 2007-04-02 |
QUALIGEN, INC. | FAST PACK TSH IMMUNOASSAY | 2006-04-03 |
QUALIGEN, INC. | FAST PACK TSH IMMUNOASSAY | 2006-04-03 |
QUALIGEN, INC. | FAST PACK TSH IMMUNOASSAY | 2006-04-03 |
Qualigen, Inc. | FASTPACK TSH IMMUNOASSAY | 2006-01-04 |
Qualigen, Inc. | FASTPACK FREE T4 IMMUNOASSAY | 2003-07-03 |
Qualigen, Inc. | FASTPACK TESTOSTERONE CALIBRATOR | 2002-09-30 |
Qualigen, Inc. | FASTPACK CALIBRATORS | 2000-11-30 |
Qualigen, Inc. | FASTPACK CONTROL | 2000-11-29 |
Qualigen, Inc. | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | 2000-10-25 |
QUALIGEN, INC. | FAST PACK (TM) ANALYZER SYSTEM | 2000-05-18 |
| NCAGE Code | 6ES72 | QUALIGEN INC. |
| CAGE Code | 6ES72 | QUALIGEN INC. |
| SEC | 0001362067 | Qualigen Inc |
| SEC | 0001132466 | QUALIGEN INC |