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EPITOPE DIAGNOSTICS, INC.

USA · San Diego CA · www.epitopediagnostics.com

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Singapore, Israel, Russia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

77listed device types

Class I 26Class II 51Class III 0

plus 77 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

9registered devices

Class I 1Class II 8

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States77 registration records, 1 510(k), 0 PMA, 1 excluded

Brazil9 confirmed, 0 excluded

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

FDA 510(k) clearances by year

12005 · K051806

FDA listed device types

showing 8 of 77

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Enzyme Linked Immunoabsorbent Assay, Rotavirus 1Radioimmunoassay, Prolactin (Lactogen) 1Cuvette, Thermostated 1Radioimmunoassay, 17-Hydroxyprogesterone 1Radioimmunoassay, Immunoreactive Insulin 1Radioimmunoassay, Glucagon 1Reagents, Specific, Analyte 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K051806	CARE FECAL OCCULT BLOOD TEST, MODEL KT313	2005-10-03
BR	80464810784	EDI Human Anti-Giardia lamblia IgG ELISA Kit	Class II
BR	80464810785	EDI Human Anti-Giardia lamblia IgM ELISA Kit	Class II
BR	80464810578	EDI Fecal Cryptosporidium parvum Antigen ELISA kit	Class II

EPITOPE 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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