Home›USA›Personal Genome Diagnostics, Inc.

Personal Genome Diagnostics, Inc.

USA · Baltimore

✓ 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

5listed device types

Class I 1Class II 2Class III 0unclassified 2

plus 5 registration records and 2 510(k), 1 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

1active device licences

Class III 1

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States5 registration records, 2 510(k), 1 PMA

Brazil0 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: PERSONAL GENOME DIAGNOSTICS INC. · GENOME DIAGNOSTICS B.V.

FDA 510(k) clearances by year

12020 · K192063

12024 · DEN230046

FDA listed device types

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids 1Next Generation Sequencing Based Tumor Profiling Test 1Synthetic Next-Generation Sequencing Quality Control And Filler Material 1Tumor Gene Profiling Test 1Reagents For Molecular Diagnostic Test Systems 1

Market	Identifier	Name	Class / date
US	DEN230046	PGDx elio plasma focus Dx	2024-08-01
US	K192063	PGDx elio tissue complete	2020-04-24
CA	73368	ALLELESEQR HLA SEQUENCING KITS	Class III

Personal Genome Diagnostics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies