Home›USA›LOUISVILLE APL DIAGNOSTICS, INC.

LOUISVILLE APL DIAGNOSTICS, INC.

USA · Seabrook

✓ Record-verifiedregistrations found in 3 markets

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

2listed device types

Class I 0Class II 2Class III 0

plus 5 registration records and 3 510(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

6active device licences

Class II 6

TWTaiwanTFDA

1valid device licences

Class II 1

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 States5 registration records, 3 510(k), 0 PMA, 1 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: LOUISVILLE APL DIAGNOSTICS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K021398	APL IGA ELISA KIT	2002-08-27
US	K984102	ACL/APS FACS KIT	1999-03-18
US	K933588	APHLELISA KIT	1994-10-13
CA	9089	ACL-APS FACS KIT	Class II
CA	11627	ANTIPHOSPHOLIPID AB KIT	Class II
CA	75334	LAPL AB2GPI HRP ELISA KIT	Class II

LOUISVILLE APL 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