Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015209536

FEI Number

3015209536

Entity Name

Privapath Diagnostics Ltd

City/State/Country

Dublin 11, IE

Establishment Address

Unit 1, Northern Cross Business Park, North Road, Dublin 11 D11 XT26, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LetsGetChecked Inc. (Owner Number: 10056783)

Owner / Operator Contact Address

PrivaPath Diagnostics Ltd t/a Lets Get Checked 3rd Floor, Block 1, West Pier Business Campus,, Dun Laoghaire Co.Dublin A96 F8C0, Dublin, IE-D A96 F8C0, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Simple 2 Test LetsGetChecked Urine Sample Collection Kit LetsGetChecked Saliva Sample Collection Kit LetsGetChecked Vaginal Sample Collection Kit LetsGetChecked Blood Sample Collection Kit LetsGetChecked Blood and Saliva Collection Kit LetsGetChecked ImPress LetsGetChecked Saliva Sample Collection Kit LetsGetChecked Multisite Sample Collection Kit LetsGetChecked Stool Sample Collection Kit LetsGetChecked Saliva Sample Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QYA	System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home	Microbiology	Class 2	866.3385	2024-11-29
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2019-03-06
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2024-05-08
MXB	Test, Vaginal, Bacterial Sialidase	Microbiology	Class 1	866.2660	2019-03-22
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2018-01-23
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-03-11
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2024-11-29
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2025-05-23
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2019-03-22

Official Correspondent

Karen Walsh

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

LetsGetChecked Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020139194	LetsGetChecked Inc.	Cucamonga, CA, US
3042854290	LetsGetChecked Inc	City View Heights, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3020139194	LetsGetChecked Inc.	Cucamonga, CA, US
3042854290	LetsGetChecked Inc	City View Heights, OH, US
3005248192	ABBOTT MOLECULAR, INC.	Des Plaines, IL, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
3021179642	NEELYX LABS	Wood Dale, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015209536. Last updated year: 2026. Please use registration number 3015209536 when referencing this establishment in official correspondence.