- 2016
On February 6, 2016, the company was founded.
It obtained 2 medical device classifications from the National Food and Drug Administration (NFDA).
- 2017
Obtained 2 additional medical device classifications from the State Food and Drug Administration.
Awarded 2 key technological innovation projects by Qingdao Municipal Enterprises.
Listed as a "Thousand Sail Enterprise" by the Qingdao Municipal Government.
Recognized as a "Science and Technology-based Small and Medium-sized Enterprise" by the Ministry of Science and Technology of China.
- 2018
Secured 3 national analysis software copyrights.
Granted 11 in-vitro diagnostic reagent class I records.
Acquired the medical device production record certificate.
Obtained 1 national art work registration certificate.
Registered 1 national trademark.
Led to the acquisition of 6 national utility model patents.
Dubbed a high-tech enterprise by the Qingdao Science and Technology Bureau.
- 2019
Authorization of 24 in-vitro diagnostic reagents with first-class records.
The attainment of the Qingdao Specialized New Product status for the Cytokine Detection Kit series.
Acquisition of the Class II Medical Device Business Record Certificate.
Secured the project for "Key Technology Research on Scale Preparation and Application of Marine Fluorescent Protein" under the Shandong Key Research and Development Program, a major scientific and technological innovation endeavor.
Honored by the Qingdao Municipal Government as an enterprise specializing in new products (technology).
- 2020
Awarded the project for "Industrialization of flow cytometry and flow immunofluorescence in vitro diagnostic reagents" within the Qingdao Key R&D Program.
Undertook a vital project for "Research and Development of Rapid Multiple Diagnostic Test Technology and Equipment for New Coronavirus Infection" as part of the Shandong Key R&D Program, addressing emergency technology for the pneumonia epidemic caused by the novel coronavirus.
The cytokine test kit was included in the "Fourth Batch of Equipment List for Epidemic Prevention and Control" by the China Medical Equipment Association.
Gained Class II medical device registration certificates for 12 cytokine calibration products used in vitro diagnostic reagents.
Obtained the production license for Class II medical devices.
Secured the registration certificate for Class II medical devices, including fully automatic flow cytometers with 2-laser 6-color and 2-laser 4-color capabilities.
Acquired 1 design patent along with 14 software copyrights.
Completed tens of millions in Series A financing, exclusively invested by Sequoia Capital.
Included among the first batch of above-scale enterprises in 2020.
- 2021
Certification of ISO13485 and ISO9001 quality management systems.
Grants of 2 invention patents and 5 utility model patents.
Authorization of 12 in vitro diagnostic reagents with Class I records.
Acquisition of the Class I medical device record for flow cytometry sample lysers.
Distinction as a "Shandong Province Specialized New Enterprise."
Recognition as a "gazelle enterprise" in Shandong Province.
- 2022
Obtained Class II medical device registration certificates for IL-1B, IL-2/IL-4/L-5/IL-6/IL-8/IL-10/IL-12p70/IL-17/IFN-γ/TNF-α/IFN-α quality control products.
Secured 8 more Class II medical device registration certificates for various in vitro diagnostic reagents.
Granted 23 in vitro diagnostic reagent class I registration numbers.
Earned CE certification for 19 products.
Obtained 11 medical device classification numbers from the State Drug Administration.
Acquired 7 invention patents, complemented by 3 appearance patents and 1 utility model patent.
- 2023
Secured 18 filing numbers for in vitro diagnostic reagents of Class and acquired 2 registration certificates for in vitro diagnostic reagents of Class II.
Granted 5 invention patents and 1 design patent.
Obtained 82 approvals from the U.S. Food and Drug Administration (FDA).
Completed hundreds of millions of yuan of Series B financing,CITC medical fund taking the lead.