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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.

Place of Origin:CHINA
Material:Stainless Steel
Application:Construction Machinery
Color:Sliver
Warranty:1 Year
MOQ:1 Pieces
Type:Fittings

Packaging & Delivery
Selling Units:Single item
Single package size: 20X8X8 cm
Single gross weight:0.500 kg
Package Type:normally packing

Intel Core I5-6500 6M Cache 2.93Ghz 800MHz FSB

One of the most famous of all Thai foods, and what I think is one the best soups in the world, is Thai tom yum goong.What I love most about tom yum goong is the flavors of lemongrass, galangal, kaffir lime leaves, fresh Thai chilies, and fresh lime juice, that all combine to create a healthy and soothing broth that will light up your taste buds.
If youâ??re looking to cook an awesome and authentic soup, try our tom yum soup sauce.
This sauce can help you enjoy Thailand food in your own home!

Spicy dry pot sauce or barbecue sauce, a version of the classic hot pot in which the items are stir-fried in plenty of spice-infused oil, with a combination of sliced beef, short ribs, chicken wings, tilapia and prawns. You'll start spooning it all over rice and wonder why you can't stop. This dish is all about the spice oil. Dry pot dish(å¹²é??ï¼? uses a bunch of ingredients that can be found in China (the chef has them specially mailed or took to the local restaurants from China). However, how do you highlight the staple aromatics? the most important being Sichuan peppercorns. Named after the region of China where they come from, these peppercorns produce a pleasant numbing sensation in your mouth (which in Chinese is called m�¡l� ). This dish truly wouldn't be the same without them.

Price FOB China in USD: 0.80
Minimum Order Qty: 1 Million Pieces
Capacity: 3 million/day
Packaging: 2000 Pcs/carton
Sample: Available. Sample Cost By Buyer

Model: KN95
Seller Code: KN95 face mask
Standards: En149:2001+a1:2009, gb2626-2006
Certificates: CE Certificate