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INOVA DIAGNOSTICS , INC.

USA · San Diego

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

46listed device types

Class I 7Class II 39Class III 0

plus 128 registration records and 138 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

133registered devices

Class I 4Class II 129

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

73active device licences

Class II 73

236 including historic records

TWTaiwanTFDA

41valid device licences

Class I 2Class II 39

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 1IVD Class 2 1

HKHong KongMDACS

55valid listings

IVD B 54IVD C 1

ILIsraelAMAR

2registrations

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 States128 registration records, 138 510(k), 0 PMA, 2 excluded

Brazil133 confirmed, 2 excluded

Canada73 confirmed, 0 excluded

Manufacturer names merged into this page: INOVA DIAGNOSTICS, INC. · INOVA DIAGNOSTICS INC · INOVA DIAGNOSTICS, INC · INOVA DIAGNOSTICS , INC. · INOVA DIAGNOSTICS, INC .

FDA 510(k) clearances by year

22004

62005

32006

42007

52008

22010

22011

22012

32013

12014

92015

32016

42017

22018

12019

12020

22021

12023

12024

12026

FDA listed device types

showing 8 of 46

Anti-Rnp Antibody, Antigen And Control 1Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1Calibrator, Secondary 1Anti-Dna Indirect Immunofluorescent Solid Phase 1Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use 1Complement C1q, Antigen, Antiserum, Control 1System, Test, Rheumatoid Factor 1Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243979	Aptiva APS IgA Reagent	2026-02-06
US	K223093	Aptiva APS IgG Reagent; Aptiva APS IgM Reagent	2024-12-17
US	K213403	Aptiva CTD Essential Reagent	2023-09-29
BR	80003610494	QUANTA Flash® CTD Screen Plus Calibradores	Class II
BR	80003610490	QUANTA Flash® Scl-70 Controles	Class II
BR	80003610491	QUANTA Flash® Jo-1 Calibradores	Class II
CA	2194	NOVA LITE MK	Class II
CA	3131	NOVALITE ADRENAL	Class II
CA	3843	QUANTA LITE ACA IGG/IGM	Class II

INOVA 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)

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