AZURE BIOTECH INC

FDA Device Registration & Listing · Houston, TX, US · Registration 3014862351

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
3014862351
FEI Number
3014862351
Entity Name
AZURE BIOTECH INC
City/State/Country
Houston, TX, US
Establishment Address
10400 Main Street, Houston, TX 77025, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Azure Biotech Inc (Owner Number: 10058544)
Owner / Operator Contact Address
10400 Main Street, Houston, TX 77025, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Fastep COVID-19 Antigen Home Test Fastep COVID-19 Antigen Pen Home Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2023-11-17

Official Correspondent

Frank Luo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2023 Jiangsu Well Biotech Co., Ltd. No N
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014862351. Last updated year: 2026. Please use registration number 3014862351 when referencing this establishment in official correspondence.
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