Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013332582

FEI Number

3013332582

Entity Name

INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.

City/State/Country

Qian'an Hebei, CN

Establishment Address

No.699 Juxin Street,High-tech Industrial Development Zone, Qian'an Hebei 064400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. (Owner Number: 10059626)

Owner / Operator Contact Address

NO.699 JUXIN STREET,HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE, Qian'an, CN-HE 064400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250398

PMA Number

N/A

All Registered Proprietary Names

LH Ovulation Rapid Test Strip LH Ovulation Rapid Test Cassette LH Ovulation Rapid Test Midstream Innovita Flu A/B Antigen Rapid Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2019-02-05
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2025-07-10

Official Correspondent

Yan Hua

US Agent Details

Fiona Wang Business: Neptune Technology INC Email: fiona@saludeusa.com Phone: (949) 8749889

Related Public Records

Same Entity

INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY 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-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013332582. Last updated year: 2026. Please use registration number 3013332582 when referencing this establishment in official correspondence.