Deng G - Search Results

1

[Ideas and Briefing about Regulatory Requirements for Laboratory Developed Tests in the US].

Han Z, Zhao Y, L Y, Dong J, Deng G. Han Z, et al. Among authors: deng g. Zhongguo Yi Liao Qi Xie Za Zhi. 2022 Sep 30;46(5):534-537. doi: 10.3969/j.issn.1671-7104.2022.05.012. Zhongguo Yi Liao Qi Xie Za Zhi. 2022. PMID: 36254482 Chinese.

2

[Study on the Disclosure System of the Evaluation and Approval Information of Medical Device Review in Japan].

Chen M, Deng G, Liu J. Chen M, et al. Among authors: deng g. Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Sep 30;42(5):357-360. doi: 10.3969/j.issn.1671-7104.2018.05.013. Zhongguo Yi Liao Qi Xie Za Zhi. 2018. PMID: 30358351 Chinese.

3

Comparison and application of different immunoassay methods for the detection of SARS-CoV-2.

He J, Hu P, Gao Y, Zheng S, Xu C, Liu R, Fang L, Li R, Han C, An J, Dong J, Deng G, Sun L, Lv Y. He J, et al. Among authors: deng g. J Med Virol. 2020 Nov;92(11):2777-2784. doi: 10.1002/jmv.26187. Epub 2020 Jul 14. J Med Virol. 2020. PMID: 32543753 Free PMC article.

4

Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests.

Li H, He J, Bao W, Wang P, Lv Y, Xu C, Hu P, Gao Y, Zheng S, An J, Deng G, Dong J. Li H, et al. Among authors: deng g. Bioanalysis. 2021 Jan;13(2):77-88. doi: 10.4155/bio-2020-0219. Epub 2021 Jan 11. Bioanalysis. 2021. PMID: 33427483 Free PMC article.

5

Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China.

Li H, Jiao T, Wang P, An J, Deng G, Sun L, Dong J. Li H, et al. Among authors: deng g. Bioanalysis. 2021 Dec;13(23):1731-1741. doi: 10.4155/bio-2021-0166. Epub 2021 Nov 15. Bioanalysis. 2021. PMID: 34779648 Free PMC article.

6

[Study on the Medical Device Registration Submission Dossier Requirements in China].

Chen M, Zhang C, Liu Y, Yuan P, Deng G. Chen M, et al. Among authors: deng g. Zhongguo Yi Liao Qi Xie Za Zhi. 2022 Jul 30;46(4):428-432. doi: 10.3969/j.issn.1671-7104.2022.04.016. Zhongguo Yi Liao Qi Xie Za Zhi. 2022. PMID: 35929160 Chinese.

7

[Resolved Problems of EGFR Mutation Detection Reagent Registration Application].

Wu C, Huang J, An J, Deng G. Wu C, et al. Among authors: deng g. Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Jul 30;41(4):289-291. doi: 10.3969/j.issn.1671-7104.2017.04.015. Zhongguo Yi Liao Qi Xie Za Zhi. 2017. PMID: 29862792 Chinese.

8

[Understanding and Thinking on America Clinical Evaluation of Medical Devices].

Yuan F, Yuan P, Deng G. Yuan F, et al. Among authors: deng g. Zhongguo Yi Liao Qi Xie Za Zhi. 2015 Sep;39(5):372-5, 387. Zhongguo Yi Liao Qi Xie Za Zhi. 2015. PMID: 26904887 Chinese.

9

Comparison of requirements for clinical study of SARS-CoV-2 antigen test kits in China, the USA and Europe.

Lyu Y, Zhu Y, Zhang Y, Hou Y, Zhang Y, He J, Deng G. Lyu Y, et al. Among authors: deng g. Bioanalysis. 2023 May;15(10):581-589. doi: 10.4155/bio-2023-0042. Epub 2023 Jun 6. Bioanalysis. 2023. PMID: 37278334 Review.

10

Regulatory considerations for animal studies of biomaterial products.

Cheng M, Liu W, Zhang J, Zhang S, Guo Z, Liu L, Tian J, Zhang X, Cheng J, Liu Y, Deng G, Gao G, Sun L. Cheng M, et al. Among authors: deng g. Bioact Mater. 2021 Oct 2;11:52-56. doi: 10.1016/j.bioactmat.2021.09.031. eCollection 2022 May. Bioact Mater. 2021. PMID: 34938912 Free PMC article.

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