Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016850770

FEI Number

3016850770

Entity Name

BIOHIT HEALTHCARE (HEFEI) CO., LTD.

City/State/Country

Hefei Anhui, CN

Establishment Address

Biouhan Bio-Industrial Park, Northeast Corner, Intersection of Kongquetai Road and Chang'an Road, High-tech Zone, Hefei Anhui 230000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biohit Healthcare (Hefei) Co., Ltd. (Owner Number: 10069805)

Owner / Operator Contact Address

Biouhan Bio-Industrial Park, Northeast Corner, Intersection of Kongquetai Road and Chang'an Road, High-tech Zone, Hefei, CN-AH 230000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iHealth COVID-19/Flu A&B Rapid Test ( Model no. ICF-3000) iHealth Flu A&B/COVID-19/RSV Rapid Test (model: ICR-3000) SARS-CoV-2 IgM/IgG Antibody Test kit (Colloidal Gold Method)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-05-10
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-10-20
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2026-03-17
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-16

Official Correspondent

Linda Wang

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

Biohit Healthcare (Hefei) Co., Ltd.

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 3016850770. Last updated year: 2026. Please use registration number 3016850770 when referencing this establishment in official correspondence.