Catering equipment.
Catering equipment.
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
Face mask medical coverall.Business consulting, business opportunities introduction, business background dd
Mask, Goggles, Latex Gloves, Infrared Thermometer and Protective Clothing.ODM & OEM Service, Trades Distributors, designing and manufacturing
Kn95 On CDC List and N95 NIOSH Nitrile Gloves..FOB CIF
Keychain, magnet, paperclip, luggage tag, mobile strap, pencil topper, keycap, charms, jibbiz, mug, notebook, memo pad, plush keychain, car accessories.OEM/ODM services are welcome, importers, distributors, agents, multiple retailers, retailers, departmental stores
Temperature and pressure relief valve, safety valves, pressure reducing valve, automatic filling valve.OEM, ODM
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
3PLY Non Woven Face Mask Size : 18cm x 9.5cm Color : Blue 70% Nonwoven 30% Melt Blown Nonwoven Price FOB CHINA in USD: 0.10 per piece Packaging: 50 pieces per box or 50 pcs per bag; 10 boxes/bags per carton. MOQ: 1 Million Pieces PRODUCTION CAPACITY: 5 million/Day Payment condition : TT, LC (if order qty is 10 mil or more) Shipping Duration : 7 DAYS ( ONE WEEK) Origin : CHINA Condition: Subject to availability
.Logistic Service
.Transit service
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Medical isolation mask, medical protective hood, medical protective coverall, medical goggle, kn95, n95, surgical face mask, medical protective mask, anesthesia mask, silicone mask, endoscope mask, medical isolation gown, covid 19 testing kit ..Customer tailor made services
Industry mahcinery, hotel hard deco. and soft deco. materials, spring bed materials, chemical, towel, bed suits, sheet, etc..Import and export services
Pcb flexible printed circuit board.
Medical supplies, clothing, daily necessities, household appliances, cosmetics, stationery, office supplies, digital products, communication equipment, electronic products, components.Trade services,Customs clearance,Freight
.Export agent, trading and freight services
N95-masks.
