Home›USA›Microgenics Corporation

Microgenics Corporation

USA · Fremont

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

67listed device types

Class I 17Class II 49Class III 0unclassified 1

plus 139 registration records and 128 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

55registered devices

Class II 55

83 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

39active device licences

Class II 26Class III 13

213 including historic records

TWTaiwanTFDA

155valid device licences

Class I 3Class II 152

SGSingaporeHSA SMDR

57device registrations

CLASS B 25CLASS C 25CLASS D 7

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

IVD import 5

AUAustraliaTGA ARTG

18active ARTG entries

IVD Class 2 17IVD Class 3 1

HKHong KongMDACS

28valid listings

IVD B 8IVD C 16IVD D 4

ILIsraelAMAR

21registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 3

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 States139 registration records, 128 510(k), 0 PMA

Brazil55 confirmed, 0 excluded

Canada39 confirmed, 0 excluded

Manufacturer names merged into this page: Microgenics Corporation · MICROGENICS CORPORATION

FDA 510(k) clearances by year

22000

42001

12002

62003

52004

22005

22006

32009

12010

112011

22012

42013

12015

22017

42018

22019

12021

12022

22023

22024

FDA listed device types

showing 8 of 67

Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Gentamicin 1Enzyme Immunoassay, Benzodiazepine 1Cyclosporine 1Calibrator, Secondary 1Fluorescence Polarization Immunoassay, Tobramycin 1Calibrator, Primary 1Enzyme Immunoassay, Quinidine 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243498	Alinity c Benzodiazepines Reagent Kit	2024-12-11
US	K240670	DRI Ecstasy Plus Assay	2024-10-30
US	K231020	Alinity c Tricyclic Antidepressants Reagent Kit	2023-11-17
BR	80254180402	Família QMS Amikacin Immunoassay	Class II
BR	80146501927	Opiates Low Calibrators	Class II
BR	80146501931	Cocaine	Class II
CA	60835	LIQUID OPIATE CONTROLS	Class II
CA	62379	ETHYL ALCOHOL CONTROL	Class II
CA	62396	SERUM SALICYLATE CALIBRATOR KIT	Class II