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·게시물 작성시 매매게시물, 허위사실유포, 욕설 비방, 광고성, 뉴스무단복제(기타저작권)등은 삭제및 IP차단합니다
·당사는 장외매매 및 거래에 일체 관여하지 않으며 38직원을 사칭해 거래하는 경우 신고해 주십시오(38법무팀)
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제목 : [오상헬스케어]콤보키 |
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글쓴이 : Naholro |
작성일 : 2024-03-27 06:08:31 |
조회수 : 326
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March 21, 2024 Lisa Baumhardt, MS, MJ, MT(ASCP), RAC, FRAPS Senior Medical Device Regulatory Expert Hyman, Phelps & McNamara, P.C. Representing: OSANG LLC 215 N. Marengo Ave., 3rd Floor Pasadena, CA 91101 Device: OHC COVID-19/Flu Antigen Test Pro EUA Number: EUA230042 Company: OSANG LLC Indication: Simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. 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, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Dear Lisa Baumhardt: 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)
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[오상헬스케어]콤보키,
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비상장주식거래, 장외주식시장 NO.1 38커뮤니케이션 (http://www.38.co.kr)
 광고 문의 : ☎ 1644-3830 (38커뮤니케이션) |
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