Home›USA›Clinical Diagnostics, Inc.

Clinical Diagnostics, Inc.

USA · Mchenry

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 4 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

203listed device types

Class I 68Class II 127Class III 0unclassified 8

plus 1,070 registration records and 208 510(k), 218 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

195registered devices

Class I 22Class II 173

348 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

55active device licences

Class II 39Class III 10Class IV 6

199 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

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 States1,070 registration records, 208 510(k), 218 PMA, 92 excluded

Brazil195 confirmed, 10 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada55 confirmed, 14 excluded

Manufacturer names merged into this page: LGC Clinical Diagnostics, Inc. · ORTHO-CLINICAL DIAGNOSTICS, INC. · Ortho-Clinical Diagnostics, Inc. · Ortho-Clinical Diagnostics European Support Center · ORTHO-CLINICAL DIAGNOSTICS INC. · ORTHO-CLINICAL DIAGNOSTICS

FDA 510(k) clearances by year

62005

192006

82007

42008

32009

22010

22012

32013

22015

32016

32017

22018

52019

12020

22021

32022

52023

22024

12025

12026

FDA listed device types

showing 8 of 203

Diluent, Blood Cell 1Acid, Lactic, Enzymatic Method 1Antisera, Cf, Influenza Virus A, B, C 1Antiserum, Fluorescent, Chlamydia Trachomatis 1Ferrozine (Colorimetric) Iron Binding Capacity 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Kit, Serological, Negative Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254295	Sofia Lyme FIA; Sofia 2 Campylobacter FIA	2026-07-10
US	K252393	VITROS Immunodiagnostic Products hs Troponin I Reagent Pack	2025-10-29
US	K241534	VITROS Immunodiagnostic Products Syphilis Reagent Pack	2024-08-28
BR	10269410186	LAVADORA ORTHO AUTO WASH PLUS I/II	Class I
BR	81246986837	Família Produtos para Imunodiagnóstico VITROS Reagente e Calibrador	Class II
BR	81246986893	Família VITROS® Immunodiagnostic Products Intact PTH II Reagent Pack,	Class II
CA	11059	FETALSCREEN	Class III
CA	11348	ORTHO ANTIBODY TO HBSAG ELISA TEST SYSTEM 2	Class IV
CA	12985	ORTHO SICKLE CELL CONTROLS	Class II

Clinical 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