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QUALIGEN, INC.

USA · Carlsbad

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 4Class II 7Class III 0

plus 14 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States14 registration records, 15 510(k), 0 PMA

Manufacturer names merged into this page: QUALIGEN, INC. · QUALIGEN INC.

FDA 510(k) clearances by year

32000

22002

12003

12006

22007

12010

12011

22013

12015

12019

FDA listed device types

showing 8 of 11

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers 1Visual, Pregnancy Hcg, Prescription Use 1Radioimmunoassay, Free Thyroxine 1Calibrator, Secondary 1Calibrator, Multi-Analyte Mixture 1Radioimmunoassay, Thyroid-Stimulating Hormone 1System, Test, Vitamin D 1Radioimmunoassay, Testosterones And Dihydrotestosterone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K182521	FastPack IP Sex Hormone Binding Globulin Immunoassay	2019-01-29
US	K141689	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
US	K123983	FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS	2013-07-03

QUALIGEN, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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