Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008163531

FEI Number

3008163531

Entity Name

EXELTIS USA, INC.

City/State/Country

FLORHAM PARK, NJ, US

Establishment Address

180 PARK AVE STE 101, FLORHAM PARK, NJ 07932, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Exeltis USA, Inc. (Owner Number: 10043621)

Owner / Operator Contact Address

180 Park Ave, Suite 101, Florham Park, NJ 07932, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NUVETEST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2019-04-19

Official Correspondent

John Kim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exeltis USA, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008163531. Last updated year: 2026. Please use registration number 3008163531 when referencing this establishment in official correspondence.