Data / Medical devices / China / INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.: FDA-registered device maker in Qian'an Hebei, China, 3 510(k) clearances
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. is registered with the FDA (registration 3013332582) in Qian'an Hebei, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 3, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013332582
- Address
- No.699 Juxin Street,High-tech Industrial Development Zone, Qian'an Hebei, China, 064400
- Owner or operator
- INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. (10059626)
- Roles
- Manufacturer
- First device listed
- February 5, 2019
- Registered through
- 2027
- Brand names listed
- INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Midstream, Innovita 2019-nCoV Ab Test (Colloidal Gold), Innovita Flu A/B Antigen Rapid Test, Innovita HCG Pregnancy Rapid Combo Test, LH Ovulation Rapid Test Cassette, LH Ovulation Rapid Test Midstream, LH Ovulation Rapid Test Strip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 3, 2025 | K250398 | Innovita Flu A/B Antigen Rapid Test | PSZ | Substantially Equivalent | Innovita (Tangshan) Biological Technology Co., Ltd. | accessdata.fda.gov |
| August 2, 2024 | K241919 | Innovita HCG Pregnancy Rapid Combo Test | JHI | Substantially Equivalent | Innovita (Tangshan) Biological Technology Co., Ltd. | accessdata.fda.gov |
| November 22, 2019 | K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent | Innovita (Tangshan) Biological Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Reagent, Coronavirus Serological
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Devices Detecting Influenza A, B, And C Virus Antigens
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
Updated July 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.