Replies to post #42467 on Predictive Technology Group Inc (PRED)

[sandman3333]

My apologies. My heart sank. I find the FDA site difficult to search. I went to the wrong list. Actually, after your message I went back and in fact it’s excellent news. Here is the list of those manufacturers who have been removed from the FDA EUA list:

The commercial manufacturers in the list below provided notification to FDA that they validated and intended to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. FDA had previously included them on the website notification list of commercial manufacturers distributing serology test kits under that policy, but they have now been removed from that notification list and placed on the list below. As noted in the guidance, if an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from the notification list. Commercial manufacturers may also voluntarily withdraw their test notification, and such tests are noted with an asterisk.

FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and FDA may take additional actions as appropriate.

Search:
Manufacturer Test
Artron BioResearch Inc./ Artron Laboratories Inc. COVID-19 IgM/IgG Antibody Test*
BestNovo (Jiangsu) Medical Technology Co., Ltd. BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit
Biobase Biodustry (Shandong) Co., Ltd. SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
BioMedomics, Inc. COVID-19 IgM-IgG rapid test*
Bioscience(Chongqing) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
Bioscience(Chongqing) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody
Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody
Boson Biotech Ltd. Co (Distributed by Pure Genetic Medical Ltd.) Rapid 2019-nCoV IgG/IgM Combo Test Card
Changchun Wancheng Bio-Electron Co., Ltd. COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)
Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Antibody Rapid Test*
Genlantis Diagnostics, Inc. CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test*
Hangzhou Clongene Biotech Co., Ltd. COMBRA COVID-19 IgM/IgG Rapid Test Cassette
Hangzhou Testsea Biotechnology Co., Ltd. One Step SARS-CoV2(COVID-19) IgG/IgM Test*
Hunan RunKun Pharmaceutical Co., Ltd. SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold)*
Jiangsu Eubo Biotechnology Co., Ltd. EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
Lifeassay Test-it COVID-19 IgM/IgG Lateral Flow Assay
Phamatech COVID19 IgG / IgM Rapid Test*
Promedical COVID-19 Rapid Test
Saladax Biomedical COVID-19 IgG/IgM Rapid Antibody Test*
Shanghai Eugene Biotech Co., Ltd. SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
Shenzen Landwind Medical Co., Ltd. COVID-19 IgG/IgM Rapid Test*
VITA Testing COVID-19 IgM/IgG Antibody Rapid Test Kit
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgM Antibody Rapid Test Kit
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgG Antibody Rapid Test Kit
Zhongshan Bio-Tech Co Ltd. SARS-CoV-2 IgM/IgG (GICA)*
Showing 1 to 27 of 27 entries



PRED and Dablood are not on this list. That is excellent news.