Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030897502

FEI Number

3030897502

Entity Name

INSTANOSIS INC.

City/State/Country

King of Prussia, PA, US

Establishment Address

1004 W 9th Avenue, Suite 10, King of Prussia, PA 19406, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Instanosis Inc. (Owner Number: 10090518)

Owner / Operator Contact Address

1004 W 9th Avenue, Suite 10, King of Prussia, PA 19406, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240295

PMA Number

N/A

All Registered Proprietary Names

InstaStrip Fentanyl Dipstick Test (Urine) InstaStrip Fentanyl Rapid Test (Urine)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-04-08

Official Correspondent

Xiaofeng Xia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Instanosis Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241741	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel	2024-07-16

Similar Registrations

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3005360469	ACRO BIOTECH Inc.	Montclair, CA, US
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3008741972	Lochness Medical	Buffalo, NY, US
3009585529	ASSURE TECH. (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN
3024463179	ACESO LABORATORIES INC.	Chino, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030897502. Last updated year: 2026. Please use registration number 3030897502 when referencing this establishment in official correspondence.