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제목 : [오상헬스케어] 콤보키트 3월21일자 FDA 승인 |
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글쓴이 : Naholro |
작성일 : 2024-03-27 06:08:31 |
조회수 : 1385 추천수 : 1 |
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Loading Time [ Sec ] CI036220 |
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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장외주식시세, 비상장주식시세표 정보제공
 비상장주식거래, 장외주식시장 NO.1 38커뮤니케이션
오상헬스케어 주주토론방,오상헬스케어 기업개요,오상헬스케어 현재가,오상헬스케어 주가,오상헬스케어 관련뉴스,오상헬스케어 주식,오상헬스케어 기업가치,오상헬스케어 실적,오상헬스케어 주당순이익,오상헬스케어 매출,오상헬스케어 상장,IPO공모,공모일정,공모주청약,청약일정,상장,공모가,주식수,청약경쟁률,청구,승인,,인포피아투자전략,종목분석,선물옵션,해외증시,주식시세 등 증권정보,증권정보사이트,증권시세,선물옵션,주가정보,종목토론,전문가,테마주 분석,추천종목,이슈,종목뉴스,차트,시황전략,주식투자,증권 전문 포털사이트,재테크,부동산,창업,카페,주식칼럼,증시브리핑,증시분석,주식투자정보,증권투자정보,금융정보,차트분석,증시일정,소액주주,커뮤니티,매매,주식거래,온라인증권,종목추전
주식,펀드,증시전망,투자포털 사이트,재무분석,주식공모,증시일정,증권사,코스피,코스닥,나스닥,거래소,주가지수,미국증시,일본증시,아시아증시,코넥스,제주식3시장,KONEX,KOSCOM,팍스넷,KOSDAQ,KOSPI,장외주식사이트,소액주주모임,비상장주식거래사이트
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