Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013296716

FEI Number

3013296716

Entity Name

Panion & BF Biotech Inc. Xizhi Second Factory

City/State/Country

New Taipei City, TW

Establishment Address

8F, No. 308-6, 308-8, Sec. 1, Datong Rd., Xizhi Dist.,, New Taipei City 221, TW

Establishment Type(s)

Manufacture Medical Device,Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Panion & BF Biotech Inc (Owner Number: 10060384)

Owner / Operator Contact Address

8F, No. 308-6, 308-8, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City, Taiwan, New Taipei City, TW-NOTA 221, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vstrip Vstrip Vstrip Vstrip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GOH	Antigens, Cf (Including Cf Control), Poliovirus 1-3	Microbiology	Class 1	866.3405	2019-05-27
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2019-05-27
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2019-05-27
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2019-05-27

Official Correspondent

Huang Chun-Hao

US Agent Details

Chingwen HO Email: chingwen17@gmail.com Phone: (971) 4077526

Related Public Records

Same Entity

Panion & BF Biotech 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
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013296716. Last updated year: 2026. Please use registration number 3013296716 when referencing this establishment in official correspondence.