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CHEMBIO DIAGNOSTIC SYSTEMS, INC.

USA · Medford

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Israel — 5 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

18listed device types

Class I 2Class II 11Class III 1unclassified 4

plus 40 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

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

1valid device licences

Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States40 registration records, 7 510(k), 0 PMA

Brazil2 confirmed, 1 excluded

Manufacturer names merged into this page: CHEMBIO DIAGNOSTIC SYSTEMS, INC. · Chembio Diagnostic Systems · CHEMBIO DIAGNOSTIC SYSTEMS, INC

FDA 510(k) clearances by year

11992 · K923925

11996 · K961965

11999 · K981913

32001 · K011551

12020 · K200506

FDA listed device types

showing 8 of 18

Infliximab Test System 1Enzyme Linked Immunoabsorption Assay, Treponema Pallidum 1Zika Virus Serological Reagents 1Test, Hiv Detection 1Dengue Serological Reagents 1Antigens, Nontreponemal, All 1Devices Detecting Influenza A, B, And C Virus Antigens 1C-Reactive Protein, Antigen, Antiserum, And Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200506	DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader	2020-06-03
US	K011551	SURE CHECK PREGNANCY TEST	2001-08-14
US	K011550	HCG STAT PAK ULTRA-FAST	2001-08-14
BR	80535240053	Família DPP® Micro Reader	Class II
BR	80142170033	Micro Leitor DPP- Bio Manguinhos	Class II

CHEMBIO DIAGNOSTIC SYSTEMS, 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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