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AUTOGENOMICS, INCORPORATED

USA · Vista

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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

10listed device types

Class I 0Class II 8Class III 2

plus 11 registration records and 3 510(k), 6 PMA

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States11 registration records, 3 510(k), 6 PMA

Manufacturer names merged into this page: AUTOGENOMICS, INCORPORATED

FDA 510(k) clearances by year

12007 · K060564

12008 · K073014

12010 · K101683

FDA listed device types

showing 8 of 10

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System 1Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr 1Test, Factor Ii G20210a Mutations, Genomic Dna Pcr 1Dna Specimen Collection, Saliva 1Instrumentation For Clinical Multiplex Test Systems 1Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System 1Test, Factor V Leiden Mutations, Genomic Dna Pcr 1Drug Metabolizing Enzyme Genotyping Systems 1

Market	Identifier	Name	Class / date
US	K101683	INFINITI CYP2C19 ASSAY	2010-10-25
US	K073014	INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN	2008-01-23
US	K060564	INFINITI SYSTEM	2007-02-07

AUTOGENOMICS, INCORPORATED

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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