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Jas Diagnostics, Inc.

USA · Miami

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

9listed device types

Class I 3Class II 6Class III 0

plus 8 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

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 States8 registration records, 21 510(k), 0 PMA, 4 excluded

Manufacturer names merged into this page: JAS Diagnostics/Drew Scientific

FDA 510(k) clearances by year

22000

112001

52002 · K022519

22008 · K080623

12014 · K130915

FDA listed device types

showing 8 of 9

Counter, Differential Cell 1Calibrator For Platelet Counting 1Calibrator For Red-Cell And White-Cell Counting 1Calibrator For Hemoglobin And Hematocrit Measurement 1Calibrator For Cell Indices 1Mixture, Hematology Quality Control 1Diluent, Blood Cell 1Products, Red-Cell Lysing Products 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130915	XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK	2014-05-15
US	K080623	CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA	2008-11-17
US	K080618	DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID	2008-05-23

Jas 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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