qualigeninc.comFastPack IP Sex Hormone Binding Globulin Immunoassay
Qualigen, Inc.
QUALIGEN, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2032087 | 3003355251 | QUALIGEN, INC. | 1 | N | 2026-01-01 | 2042 CORTE DEL NOGAL CARLSBAD CA US 92011 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816467020105 | Calibrator Kit – hCG - hCG Cal | 1-877-770-6127 | systemsupport@qualigeninc.com |
| 00816467020112 | FastPack® IP hCG Diluent Kit (25) - Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample. | 1-877-770-6127 | systemsupport@qualigeninc.com |
| 00816467020396 | FastPack® IP System - IP System | 1-877-770-6127 | systemsupport@qualigeninc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 57075 | 1565426852 | K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | CDZ | 2019-01-29 |
| 57075 | 2018507824 | K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | MRG | 2013-07-03 |
| 57075 | 1643852703 | K123725 | FASTPACK CONTROL KIT | JJY | 2013-03-08 |
| 57075 | 1405561051 | K101390 | FASTPACK TSH IMMUNOASSAY | JLW | 2010-08-13 |
| 57075 | 1657897231 | K101388 | FASTPACK TESTO IMMUNOASSAY | CDZ | 2011-02-18 |
| 57075 | 1892503345 | K072264 | FASTPACK HCG IMMUNOASSAY | JHI | 2007-12-06 |
| 57075 | 1627671186 | K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | JJX | 2007-04-02 |
| 57075 | 1344466024 | K052301 | FASTPACK TSH IMMUNOASSAY | JLW | 2006-01-04 |
| 57075 | 1734552854 | K030329 | FASTPACK FREE T4 IMMUNOASSAY | CEC | 2003-07-03 |
| 57075 | 1026489606 | K022533 | FASTPACK TESTOSTERONE CALIBRATOR | JIT | 2002-09-30 |
| 57075 | 1135911351 | K003096 | FASTPACK CALIBRATORS | JIT | 2000-11-30 |
| 57075 | 1706454086 | K003095 | FASTPACK CONTROL | JJX | 2000-11-29 |
| 57075 | 1489760024 | K003094 | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | LTJ | 2000-10-25 |
| 57075 | 1910584664 | ||||
| 57075 | 1949680226 |
Product Codes Associated With Registrations#
PMN#
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
Qualigen, Inc.
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
Qualigen, Inc.
FASTPACK CONTROL KIT
Qualigen, Inc.
FASTPACK TESTO IMMUNOASSAY
Qualigen, Inc.
FASTPACK TSH IMMUNOASSAY
Qualigen, Inc.
FASTPACK HCG IMMUNOASSAY
Qualigen, Inc.
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
Qualigen, Inc.
FASTPACK TSH IMMUNOASSAY
Qualigen, Inc.
FASTPACK FREE T4 IMMUNOASSAY
Qualigen, Inc.
FASTPACK TESTOSTERONE CALIBRATOR
Qualigen, Inc.
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
Qualigen, Inc.
FASTPACK CALIBRATORS
Qualigen, Inc.
FASTPACK CONTROL
Qualigen, Inc.
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
Qualigen, Inc.
GUDID#
FastPack® IP System - IP System
2024-09-27
FastPack® IP System - IP System
2024-09-27
FastPack® IP hCG Kit (30) - 30 Test Ported hCG Immunoassay Kit
2016-09-16
Calibrator Kit – hCG - hCG Cal
2016-09-16
FastPack® IP hCG Diluent Kit (25) - Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample.
2016-09-16
FastPack® Testo Kit (50) - 50 Test Non-Ported Testo Immunoassay Kit
2016-09-16
FastPack® IP Testo Kit (30) - 30 Test Ported Testo Immunoassay Kit
2016-09-16
FastPack® IP Testo Kit (90) - 90 Test Ported Testo Immunoassay Kit
2017-09-14
Calibrator Kit - Testosterone - Testo Cal
2016-09-16
FastPack® Control Kit - Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG
2016-09-16
FastPack® Pro System - RoHS Compliant 7-chamber FastPack System
2020-08-05
FastPack® IP System - IP System
2016-09-16
FastPack® IP System - RoHS Compliant FastPack System
2016-09-16
FastPack SARS-CoV-2 IgG - 90 Test Kit SARS-CoV-2 IgG Immunoassay
2020-08-05
FastPack SARS-CoV-2 IgG - 90 Test Kit SARS-CoV-2 IgG Immunoassay
2020-08-05
FastPack® Total PSA Kit (50) - 50 Test Non-Ported TPSA Immunoassay Kit
2016-09-16
FastPack® IP Total PSA Kit (30) - 30 Test Ported TPSA Immunoassay Kit
2016-09-16
FastPack® IP Total PSA Kit (90) - 90 Test Ported TPSA Immunoassay Kit
2017-09-14
Calibrator Kit - PSA - TPSA Cal
2016-09-16
Method Verification Kit - PSA - TPSA Verifier
2016-09-16
Control Kit - PSA - Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US.
2016-09-16
FastPack® IP SHBG - 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls
2019-03-15
FastPack® IP SHBG - 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control
2019-02-01
Method Verification Kit - Vitamin D - Vit. D Verifier
2016-09-16
FastPack® IP Vitamin D Kit Complete - 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control
2016-09-16
FastPack® IP Free T4 Kit (30) - 30 Test Ported FT4 Immunoassay Kit
2016-09-16
FastPack® IP TSH Kit (30) - 30 Test Ported TSH Immunoassay Kit
2016-09-16
Calibrator Kit – Free T4 - FT4 Cal
2016-09-16
Calibrator Kit – TSH - TSH Cal
2016-09-16