SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Shijiazhuang Hebei, CN · Registration 3017379203

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
3017379203
FEI Number
3017379203
Entity Name
SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO.,LTD
City/State/Country
Shijiazhuang Hebei, CN
Establishment Address
No.3 Building,Block C, Fangyi Science. Park, No. 365 Huai'an East Road, Shijiazhuang Hebei 050000, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shijiazhuang Hipro Biotechnology Co.,Ltd (Owner Number: 10072388)
Owner / Operator Contact Address
No.3 Building,Block C, Fangyi Tech. Park, No. 365 Huai'an East Road, Shijiazhuang, CN-HE 050000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hipro® Antistreptolysin O Test Kit (Nephelometry Immunoassay Method) Hipro® Prolactin Test Kit (Fluorescence lmmunoassay Method) Hipro® Colloidal Gold Immunoassay Analyzer Palm G Hirpo® Fluorescence Immunoassay Analyzer Palm F Hipro® Total Thyroxine Test Kit (Fluorescence Immunoassay Method) Microalbuminuric Test Kit (Nephelometry Immunoassay Method) Hipro® Retinol-binding Protein Test Kit Hipro® Alpha-1-microglobulin Test Kit (Rate Scattering Turbidimetric Method) Hipro® Progesterone Test Kit (Fluorescence Immunoassay Method) ZOAN™ FOB+TRF Combo Test Kit Hipro® Low Density Lipoprotein Cholesterol Test Kit (Enzymic Method) Hipro® Luteinizing Hormone Test Kit (Fluorescence Immunoassay Method) Hipro® Sars-Cov-2 Antibody (Nephelometry) Test Kit Hipro® Sars-Cov-2 Antibody (Colloidal Gold) Test Kit Hipro® Neutralizing Antibody (Colloidal Gold ) Test Kit Hipro® Sars-Cov-2 Antigen (Nephelometry ) Test Kit Hipro® Sars-Cov-2 Antigen (Colloidal Gold)Test Kit Hipro® Estradiol Test Kit (Fluorescence Immunoassay Method) Hipro® Beta-2-microglobulin Test Kit (Rate Scattering Turbidimetric Method) Hipro® Triglyceride Test Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 2021-10-22
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2021-11-09
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2021-11-17
CDX Radioimmunoassay, Total Thyroxine Clinical Chemistry Class 2 862.1700 2021-11-09
DDZ Albumin, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5040 2021-11-17
CZS Retinol-Binding Protein, Antigen, Antiserum, Control Immunology Class 1 866.5765 2021-11-09
MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control Immunology Class 1 866.5400 2021-11-09
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2021-11-09
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2021-11-25
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2021-11-11
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2021-11-09
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-04-28
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2021-11-09
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2021-11-09
JGW Fluorometric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2021-11-09

Official Correspondent

Weina Zheng

US Agent Details

Victor Hum Email: vhum@antigensciences.com Phone: (510) 4742800

Related Public Records

Same Entity

Shijiazhuang Hipro Biotechnology Co.,Ltd
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
K760096 Gamma Biologicals, Inc. REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O 1976-08-03
K971921 Monobind PROLACTIN (PRL) HORMONE MICROPLATE ELISA 1997-06-24
K760232 Instrumentation Laboratory CO PRINTER, IL 460 1976-08-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2009 Roche Diagnostics Corp. 1
Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017379203. Last updated year: 2026. Please use registration number 3017379203 when referencing this establishment in official correspondence.
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