Shijiazhuang Hipro Biotechnology Co., Ltd.
Registered establishment in Shijiazhuang, Hebei, China. 22 device types, 1 clearance.
Shijiazhuang Hipro Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Nephelometer, Radioimmunoassay, Estradiol and 20 other device types. Its earliest product listing with the FDA dates from 2020.
22device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017379203 |
| FEI number | 3017379203 |
| Establishment type | Manufacturer |
Location
| City | Shijiazhuang |
|---|---|
| Province | Hebei |
| Address | No.3 Building,Block C, Fangyi Science. Park |
| Postal code | 050000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Albumin, Fitc, Antigen, Antiserum, Control | Class 2 | Microalbuminuric Test Kit (Nephelometry Immunoassay Method) | 2021 | 2 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | Class 1 | Hipro® Alpha-1-microglobulin Test Kit (Rate Scattering Turbidimetric Method) | 2021 | 3 |
| Antistreptolysin – Titer/Streptolysin O Reagent | Class 1 | Hipro® Antistreptolysin O Test Kit (Nephelometry Immunoassay Method) | 2021 | 3 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | Class 1 | Hirpo® Fluorescence Immunoassay Analyzer Palm F, Hipro® Colloidal Gold Immunoassay Analyzer Palm G | 2021 | 13 |
| Enzymatic Esterase–Oxidase, Cholesterol | Class 1 | Hipro® Total Cholesterol Test Kit (Enzymic Method) | 2021 | 9 |
| Fluorometric Method, Triglycerides | Class 1 | Hipro® Triglyceride Test Kit | 2021 | 1 |
| Immunohistochemistry Reagents And Kits | Class 1 | ZOAN™ FOB+TRF Combo Test Kit | 2021 | 7 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | Class 1 | Hipro® High Density Lipoprotein Cholesterol Test Kit (Enzymic Method) | 2021 | 2 |
| Nephelometer | Class 1 | Hipro® Immunoassay Analyzer HP-083/4-II, Hipro® Automatic Immunoassay Analyzer HP-AFS/1, HP-AFS/3 | 2021 | 4 |
| Prealbumin, Antigen, Antiserum, Control | Class 1 | Hipro® Prealbumin Test Kit (Rate Scattering Turbidimetric Method) | 2021 | 3 |
| Radioimmunoassay, Estradiol | Class 1 | Hipro® Estradiol Test Kit (Fluorescence Immunoassay Method) | 2021 | 5 |
| Radioimmunoassay, Follicle-Stimulating Hormone | Class 1 | Hipro® Follicle Stimulating Hormone Test Kit (Fluorescence Immunoassay Method) | 2021 | 6 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Hipro® Luteinizing Hormone Test Kit (Fluorescence Immunoassay Method) | 2021 | 16 |
| Radioimmunoassay, Progesterone | Class 1 | Hipro® Progesterone Test Kit (Fluorescence Immunoassay Method) | 2021 | 4 |
| Radioimmunoassay, Prolactin (Lactogen) | Class 1 | Hipro® Prolactin Test Kit (Fluorescence lmmunoassay Method) | 2021 | 6 |
| Radioimmunoassay, Total Thyroxine | Class 2 | Hipro® Total Thyroxine Test Kit (Fluorescence Immunoassay Method) | 2021 | 5 |
| Radioimmunoassay, Total Triiodothyronine | Class 2 | Hipro® Free Thyroxine Test Kit (Fluorescence Immunoassay Method), Hipro® Total Thyroxine Test Kit (Fluorescence Immunoassay Method) | 2021 | 5 |
| Reagent, Coronavirus Serological | Class N | Hipro® Sars-Cov-2 Antigen (Colloidal Gold)Test Kit, Hipro® Neutralizing Antibody (Colloidal Gold ) Test Kit, Hipro® Sars-Cov-2 Antibody (Nephelometry) Test Kit, Hipro® Sars-Cov-2 Antibody (Colloidal Gold) Test Kit, Hipro® Sars-Cov-2 Antigen (Nephelometry ) Test Kit | 2020 | 12 |
| Retinol-Binding Protein, Antigen, Antiserum, Control | Class 1 | Hipro® Retinol-binding Protein Test Kit | 2021 | 3 |
| System, Test, Beta-2-Microglobulin Immunological | Class 2 | Hipro® Beta-2-microglobulin Test Kit (Rate Scattering Turbidimetric Method) | 2021 | 3 |
| System, Test, Lipoprotein(A) | Class 1 | Hipro® Lipoprotein(a) Test Kit (Rate Scattering Turbidimetric Method) | 2021 | 2 |
| System, Test, Low Density, Lipoprotein | Class 1 | Hipro® Low Density Lipoprotein Cholesterol Test Kit (Enzymic Method) | 2021 | 3 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220999 | 2024-09-12 | PDJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Factory area | 10000 sq.m. (main facility); 53.3 acres (Taizhou microfluidic base) |
| Main products | Immunoassay Analyzer, Fluorescence Immunoassay Analyzer, Home Test Kit, Diagnostic Reagent, Quality Control System |
| Certifications | 212 patents (12+ invention patents), 75+ CFDA registration certificates, 86 CE certificates, ISO 13485, NGSP |
| Export markets | 100+ countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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