Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in upper
and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider.
Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high
complexity tests.
This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and, 3. There is no adequate, approved, and available alternative to the emergency use of your
product.
4
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.
"Calcium and Magnesium removal ion exchange resin from lithium solution
Salt lake brine contains trace amounts of calcium and magnesium ions. In order to purify lithium solution, calcium and magnesium ions need to be removed. The removal of calcium and magnesium ions by ion exchange resin is a simple and effective method. The operation is simple, the resin may be regenerated, and it has high economic benefits."
"Ion Exchange Resin for Boron removal from Lithium Solution
There are trace amounts of boron ions in salt lake brine. In order to purify lithium solution, it is necessary to remove boron ions. The removal of boron by ion exchange resin method is a simple and effective method. The operation is simple, the resin may be regenerated, and it has high economic benefits."
Calcium and Magnesium removal ion exchange resin from lithium solution
Salt lake brine contains trace amounts of calcium and magnesium ions. In order to purify lithium solution, calcium and magnesium ions need to be removed. The removal of calcium and magnesium ions by ion exchange resin is a simple and effective method. The operation is simple, the resin may be regenerated, and it has high economic benefits
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Gold extraction recovery resin
In hydrometallurgy, there are many ways to separate and extract gold, among which ion exchange is one of the most important methods.
Ion exchange and adsorption separation technology has been paid more and more attention because of its advantages of high separation efficiency, simple equipment and operation, renewable and reusable resin and adsorbent, and less environmental pollution.
The gold recovery ion exchange resin produced by Jiangsu Kingshan New Material Co., Ltd. has the advantages of high mechanical strength, good selectivity and large exchange capacity, and is widely praised by customers.
"Fluorine Removal resin
Drinking water with high fluoride content is the most fundamental and important factor leading to the prevalence of fluorosis. Ionic resin exchange method has been widely used for fluoride removal.
Jiangsu Kingshan New Material Co., Ltd. provides special resin for fluorine removal with high mechanical strength, acid and alkali resistance, stable physical and chemical properties, simple regeneration, mild operating conditions, no secondary pollution to the environment, reusable, long service life, cost saving for enterprises, improve economic benefits."
"Rhodium adsorption resin
The resin method is to use ion exchange resin to recover rhodium from waste catalysts, waste electrical components, and waste electroplating solutions. It has the advantages of high separation efficiency, simple operation and recyclable resin.
The rhodium adsorption resin of Jiangsu Kingshan New Material Co., Ltd. has high selective affinity and adsorption rate, and is easy to regenerate and has high regeneration rate, and is widely used in industrial palladium metal recycling."
"Lithium extraction resin
The advantages of ion exchange adsorption method for lithium extraction are simple, high recovery rate and good selectivity.
The lithium extraction resin provided by Jiangsu Kingshan New Material Co., Ltd. has high adsorption rate of lithium, fast adsorption speed, easy desorption, and can selectively extract lithium, and the operation process is relatively simple"
"Lithium adsorption material, Lithium extraction material, Lithium adsorbent, Lithium extraction material, Lithium extraction agent
Lithium adsorption material, Bestion brand, can extract lithium ions from lithium mines, salt lakes, and the sea, and can also separate and extract lithium ions and other metal ions from waste batteries. It is a low-cost method of all lithium extraction methods. if you have requirement, please contact Jiangsu Kingshan New Material Co., Ltd. The company also provides all other metal extraction materials on the periodic table.
Jiangsu Kingshan New Material Co ., Ltd.
is a professional adsorbtion and separation materials company integrating R&D, sales and production. We are a council unit in China ion exchange resin industry with over 40 years experience of R&D of ion exchange and adsorbent functional polymer materials. We have been always focusing on the research of high-end products, filling dozens of domestic and overseas gaps.
"Rhenium Extraction resin
Rhenium is a precious rare metal, which is widely used in scientific research and modern industry. Rhenium is mostly associated in metallic minerals, and the content is very low. The particularity of the distribution of scattered metals makes it difficult to extract and recover them. Extraction of rhenium by ion exchange is a simple and efficient method.
The rhenium extraction resin provided by Jiangsu Kingshan New Material Co., Ltd. has the advantages of good stability, convenient separation, large exchange capacity, high mechanical strength, and reusability, and is widely praised by customers."
"Chromium removal ion exchange resin
The ion exchange method for chromium removal has good practical performance, low cost, convenient operation, simple equipment, good water quality, stable performance, and easy recycling. The efficiency is high, and chromium and water can be recovered and reused. Compared with the traditional method, the amount of sludge is reduced by about 80%, and the discharge standard can be met.
Jiangsu Kingshan New Material Co., Ltd. is a special ion exchange resin for chromium removal. It has high exchange capacity, strong regeneration capacity and good mechanical strength. It is widely used in the removal of chromium from wastewater."
The ion exchange method for chromium removal has good practical performance, low cost, convenient operation, simple equipment, good water quality, stable performance, and easy recycling. The efficiency is high, and chromium and water can be recovered and reused. Compared with the traditional method, the amount of sludge is reduced by about 80%, and the discharge standard can be met.
a special ion exchange resin for chromium removal. It has high exchange capacity, strong regeneration capacity and good mechanical strength. It is widely used in the removal of chromium from wastewater
"Silver recovery resin
Silver is an important precious metal that is widely used in industry and life.
The resin adsorption method for silver recovery technology has the characteristics of fast adsorption rate, high adsorption rate, convenient desorption, and is not easy to be contaminated by organic matter in the solution.
Jiangsu Kingshan New Materials Co., Ltd. provides silver recovery resin, which has high selectivity and adsorption rate, simple regeneration and high regeneration rate"
"Calcium and Magnesium removal ion exchange resin from lithium solution
Salt lake brine contains trace amounts of calcium and magnesium ions. In order to purify lithium solution, calcium and magnesium ions need to be removed. The removal of calcium and magnesium ions by ion exchange resin is a simple and effective method. The operation is simple, the resin may be regenerated, and it has high economic benefits."
