RENALYTIXAI

FDA Device Registration & Listing · Long Island City, NY, US · Registration 3018739912

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018739912
FEI Number
3018739912
Entity Name
RENALYTIXAI
City/State/Country
Long Island City, NY, US
Establishment Address
30-02 48th Avenue, Suite 150, Long Island City, NY 11101, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Renalytix (Owner Number: 10081544)
Owner / Operator Contact Address
101 6th Avenue, 3 Fl. Rm 324, New York, NY 10013, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

UACR kidneyintelX.dkd Collection Kit KidneyIntelX Collection Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2024-05-01
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2021-04-22

Official Correspondent

Anna Flynn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Renalytix
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3004111573 Sterigenics US LLC Grand Prairie, TX, US
3021179642 NEELYX LABS Wood Dale, IL, US
8020040 GREINER BIO-ONE GMBH KREMSMUENSTER Oberosterreich, AT
3011057574 The Dot Printer Inc. Irvine, CA, US
3012683224 Realtime Laboratories, Inc Carrollton, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018739912. Last updated year: 2026. Please use registration number 3018739912 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.