→ In June 5438+10, the pharmaceutical production license was obtained.
20 10 year
→ GMP certificate was obtained in 65438+February.
→ 65438+February, we obtained the inter-laboratory quality evaluation certificate of virus nucleic acid detection and inspection in the national blood collection and supply institutions of the Ministry of Health and the national inter-laboratory quality evaluation certificate of nucleic acid detection (virology).
→ In August, the new drug certificate of PCR detection reagent special for blood nucleic acid screening in blood station was obtained, and the certificate number was: National Medicine Certificate S20 100004.
→ Shanghai Haoyuan Customer Blood Station used Shanghai Haoyuan blood nucleic acid screening reagent to detect the first HIV-infected person who missed the test in China during the window period. This has played a positive role in promoting blood nucleic acid screening and improving blood safety in China.
In 2009
→ 65438+February, the medical device registration certificate of "Hepatitis B virus nucleic acid detection kit (fluorescence quantitative PCR method)" was obtained.
→ In June, 5438+10, the medical device manufacturing enterprise license was obtained.
the year of 2008
→ Obtain the medical device registration certificate of "HIV- 1 nucleic acid diagnostic kit".
→ It has passed the quality management system certification of in vitro diagnostic reagents produced by the State Food and Drug Administration of the United States.
→ Obtained the certificate of "Shanghai High-tech Enterprise" in 2008.
In 2007
→ Haoyuan NAT reagent officially entered the biological products enterprise, and semi-automatic sample preparation instrument, automatic sample adding instrument and high-sensitivity real-time fluorescence PCR detection kit were successfully developed.
→ Establish strategic alliance with Kia Corporation of Taiwan Province and TBG Corporation of the United States in the field of nucleic acid detection.
→ Obtained the invention patent of "Microfluidic Chip Reuse Method".
In 2006
→ Haoyuan NAT reagent officially entered the blood collection and supply system in China.
In 2005
→ Successfully developed the first set of PCR detection kit for blood screening.
In 2004
→ "nucleic acid amplification (PCR) microfluidic chip detection kit" was approved by Shanghai Hi-tech A-level achievement transformation project.
In 2003
→ Successfully developed the first set of PCR microfluidic chip detection kit.
→ passed the GMP certification of the US Food and Drug Administration.
→ Obtained the invention patent of "RNA molecular amplification method without reverse transcription step".
→ Obtained the invention patent of "Universal Capture Method of DNA Molecules".
→ Obtained the invention patent of "PCR amplification hybridization synchronization method".
→ Obtained the invention patent of "Method for simultaneously extracting RNA and DNA from clinical samples by virus cracking precipitation method".
In 2002
→ Obtain the production number of "Hepatitis B virus nucleic acid amplification (PCR) enzyme immunoassay kit".
200 1 year
→ "Hepatitis B virus nucleic acid amplification (PCR) enzyme immunoassay kit" was recognized by Shanghai High-tech Achievements Transformation Project.
In 2000,
→ Obtained the new drug certificate of the first PCR quantitative reagent "Hepatitis B virus nucleic acid amplification (PCR) enzyme-linked immunosorbent assay kit" in China.
1999
→ Successfully developed the first set of PCR quantitative detection kit in China.
1998
→ China introduced the first pollution prevention system of UNG/dUTP.
→ The first set of PCR internal control system was introduced in China.
→ Obtained the practical patent of "separating magnetic particles".
1997
→ Haoyuan was established.