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IVD RESEARCH, LLC.

USA · Carlsbad

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 3 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

10listed device types

Class I 5Class II 4Class III 0unclassified 1

plus 10 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States10 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: IVD RESEARCH, LLC. · IVD RESEARCH INC

FDA 510(k) clearances by year

12002 · K020583

22003 · K031059

12004 · K032897

12009 · K081064

FDA listed device types

showing 8 of 10

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni 1Immunoassay, Pregnanediol Glucuronide, Over The Counter 1Test, Luteinizing Hormone (Lh), Over The Counter 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Elisa, Trichinella Spiralis 1Cryptosporidium Spp. 1Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp 1Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K081064	GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF	2009-01-14
US	K032897	C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96	2004-05-27
US	K031059	IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96	2003-07-10
BR	10259610175	Giardia Human Fecal Antigen Detection Microwell Elisa Kit	Class II
BR	10259610092	CRYPTOSPORIDIUM HUMAN FECAL ANTIGEN DETECTION MICROWELL ELISA KIT	Class II
BR	10259610093	E. histolytica/dispar Antigen Detection Assay Microwell ELISA	Class II

IVD RESEARCH, LLC.

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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