QUALIGEN INC.

Address:2042 CORTE DEL NOGAL,CARLSBAD,CA,92011,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers (LTJ) (2) Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ) (2) Visual, Pregnancy Hcg, Prescription Use (JHI) (1) Reagent, Coronavirus Serological (QKO) (1) System, Test, Vitamin D (MRG) (1) Calibrator, Secondary (JIT) (1)

Premarket Exempt

No Yes

Clear

Control Kit - PSA - 00816467020167 Catalog Number : 25000003

Device Description : Two levels of controls for the following assays: TPSA, FPSAFPSA is not available Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US.

Device Class : 1

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

FastPack® IP System - 00816467020334 Catalog Number : 08000043-C, 08000043-CR

Device Description : RoHS Compliant FastPack System

Device Class : 1

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

FastPack® Pro System - 00816467020372 Catalog Number : 08000067, 08000067-R, 08000067-X

Device Description : RoHS Compliant 7-chamber FastPack System

Device Class : 1

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

FastPack® Total PSA Kit (50) - 10816467020010 Catalog Number : 25000001

Device Description : 50 Test Non-Ported TPSA Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : LTJ

Prescription Use : Yes

Device Count : 50

FastPack® Testo Kit (50) - 10816467020034 Catalog Number : 25000009

Device Description : 50 Test Non-Ported Testo Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 50

FastPack® IP hCG Kit (30) - 10816467020126 Catalog Number : 25000044

Device Description : 30 Test Ported hCG Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 30

FastPack® IP Vitamin D Kit Complete - 10816467020157 Catalog Number : 25000068, 25000073

Device Description : 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : MRG

Prescription Use : Yes

Device Count : 30

FastPack® IP SHBG - 10816467020348 Catalog Number : 25000080

Device Description : 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJX, JIT, CDZ

Prescription Use : Yes

Device Count : 60

FastPack SARS-CoV-2 IgG - 10816467020386 Catalog Number : 25000085

Device Description : 90 Test Kit SARS-CoV-2 IgG Immunoassay

Device Class :

Duns Number: 959103565

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 90

FastPack® IP Total PSA Kit (30) - 20816467020017 Catalog Number : 25000040

Device Description : 30 Test Ported TPSA Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : LTJ

Prescription Use : Yes

Device Count : 30

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