how to use clungene rapid test kit

Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. SPECIMEN COLLECTION FOR THE NASOPHARYNGEAL SWAB, SPECIMEN COLLECTION FOR THE OROPHARYNGEAL SWAB. To buy in this shop you have to be registered user. Declaration-of-conformity-Clungene-Antigen-Rapid-Test.pdf, Clinical-Study-Report-Clungene-Antigen-Rapid-Test.pdf, Sicherheitsdatenblatt-zum-Clungene-Antigen-Schnelltest.pdf, Safety-Data-Sheet-Clungene-Antigen-Rapid-Test.pdf, Deutsche-Evaluierung-Paul-Ehrlich-Institut.pdf, EU-common-list-of-COVID-19-rapid-antigen-tests.pdf, Gebrauchsanweisung-Clungene-Antigen-Schnelltest.pdf, Instruction-for-Clungene-Antigen-Rapid-Test.pdf, fast and reliable test results in only 15 minutes, can be performed with naso- and oropharyngeal samples, no cross-reactivity with other corona viruses like MERS, 229E, NL63, KHU1 or influenza A, B, for healthcare professionals and specialists at locations close to patients, do not use this product as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for information on the infection status of COVID-19, please read all information in this package insert before performing the test, the detection kit should be stored in a sealed pouch before use, all specimens should be classified as potentially hazardous and treated as an infectious agent, the used detection kit should be disposed of according to federal, state and local regulations, 25 test cassettes: Each test cassette packed in foil bags with desiccant, 25 extraction reagent: ampoule bottle with 0.3 ml extraction reagent, 25 sterilized swabs: disposable swabs for specimen collection, store it in the sealed pouch at a temperature (4-30 °C or 40-86 °F). Lituo single packed civil use Antigen Rapid Test Kit (Anterior Nasal) TFT OLED Medical Fingertip wearable pulse oximeter; Clungene single packed saliva antigen rapid self test kit; Dasheng DTC3X Civil PPE Niosh N95 half respirator mask; Sms pp short sleeve V … Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing. Q: What States or territories have chosen to authorize laboratories within that State or territory to develop and perform a test for COVID-19 under the policy outlined in Section IV.B of the Policy for Coronavirus Disease-2019 Tests? • fast and reliable test results in only 15 minutes A.S., Diagnovital SARS-CoV-2 Multiplex, BIONEER Corporation, AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit, Thermo Fisher Scientific, TaqPath™ COVID 19 High Throughput Combo Kit (also called "The Amplitude™ Solution with the TaqPath™ COVID 19 High Throughput Combo Kit"), Ortho Clinical Diagnostics VITROS Immunodiagnostic Products SARS-CoV-2 Ag Assay (Reagent Pack / Calibrators), LMSI, LLC d/b/a Lighthouse Lab Services, CovidNow SARS-CoV-2 Assay Kit, Ender diagnostics ag, Ender LAB COVID-19 isothermal PCR detection kit, LuminUltra Technologies Ltd., GeneCount® COVID-19 RT-qPCR Assay Kit, Jiangsu Code Biomedical Technology Co. Ltd., CodeCheckSARS-CoV-2 RT-PCR Kit, Applied Biological Materials Inc. (abm), GenomeCoV19 Detection Kit, LGC Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test, Merlin Biomedical (Xiamen) Co. Ltd., Novel Coronavirus (COVID-19) RT-PCR Kit, Genedrive Diagnostics Ltd., Genedrive ®96 SARS-CoV2 kit, Tetracore, Inc., EZ-SARS-CoV-2 Real-Time RT-PCR, BioGenex Laboratories, Inc., BGX COVID-19 RT-PCR, Beckman Coulter Access SARS-CoV-2 Antigen, GreenRoads Diagnostics LLC, GreenRoads Dx SARS-CoV-2™ Test, MiRXES Pte Ltd,  MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test, LMSI, LLC d/b/a Lighthouse Lab Services, SalivaNow SARS-CoV-2 Assay Kit, Ä°DÄ°L BÄ°OTECH ARAŞTIRMA SAN. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Negative results do not preclude acute SARS-CoV-2 infection. The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay method for the qualitative detection of SARS CoV-2 nucleocapsid antigen in nasopharyngeal and oropharyngeal swabs from individuals suspected by their healthcare provider to be COVID-19 infected. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. Tests that have been issued an EUA can be found on the EUA page. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. Note that many other laboratories, including public health, commercial, and healthcare system/academic laboratories, around the country are providing testing for COVID-19 using an EUA authorized test. Rapid tests are excluded from return and exchange. datenschutz@ossenberg.com, Clungene® COVID-19 Antigen Rapid Test Box of 25. 48432 Rheine, Tel: +49 (0) 5971-98046-0 As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Fax: +49 (0) 5971-98046-16, info@ossenberg.com Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. d/b/a Innovative Gx Laboratories, Premier Medical, Inc. dba Premier Medical Laboratory Services, UofSC College of Pharmacy Diagnostic Genomics Laboratory, Elite Medical Laboratory Solutions LLC dba Diax Labs, Capital Digestive Care, LLC., Laboratory Services, Diagnostic Laboratory Services, Inc. (HI), IDL Acquisition Co., LLC DBA MDx Laboratory Services, Molecular Diagnostics Laboratory, Department of Pathology, Yale School of Medicine, Loma Linda University Medical Center Clinical Laboratory, Northwestern Medicine Diagnostic Molecular Lab, BD BioGx SARS-CoV-2 Reagents for BD MAX System, Biomeme, Inc. Biomeme SARS-CoV-2 test kit, Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit, OPTOLANE Technologies Inc. Kaira 2019-nCoV Detection Kit, OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit, QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel Assay, YD Diagnostics Corp. MolecuTech Real-Time COVID-19, LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay kit, GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit, Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit, ZhuHai Sinochips Bioscience Co., Ltd COVID-19 Real-time PCR Test Kit, GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2, American BioSources Inc., DBA Genomic Diagnostics GDx GrandPerformance SARS-CoV-2 Detection Kit, Taigen Bioscience Corporation LabTurbo AIO COVID-19 RNA Testing kit, ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay, Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay, MiCo BioMed Co., Ltd. Veri-Q COVID-19 Multiplex Detection Kit, Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay, SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit, Enzo Life Sciences, Inc. Enzo AMPIPROBE® SARS-CoV-2 Test System, Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0, GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel), NovaTec Immundiagnosticsa GmBH GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR, TAAG Genetics S.A. nPLEX SARS-CoV-2 Detection Kit, Illucidx Inc., Illucidx COVID-19 Dx RT-LAMP, BioZentech Co., Ltd., BZ QPCR COVID-19 Kit, Molecular Epidemiology Inc., IEH SARS-CoV-2 RT-PCR Test, Suzhou PreciGenome, Ltd., Co., Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR), GK Pharmaceuticals Contract Manufacturing Operations, ACCU-RIGHT SARS-COV-2 RT-PCR KIT, GUANGDONG ARDENT BIOMED Co., Ltd, Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe), Nanjing Liming Bio-Products Co., Ltd., StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit, Hologic Aptima SARS-CoV-2 Assay Pooled Samples Workflow, Hologic Panther Fusion SARS-CoV-2 Assay Pooled Samples Workflow, DowGene Co., Ltd., Dow QuickFinderTM 2019-nCov Real-Time PCR Kit, Shimadzu Corporation, 2019 Novel Coronavirus Detection Kit, ProteomeTech Inc. GENEdania COVID-19 qRT-PCR, GenMark Diagnostics, Inc., eSensor SARS-CoV-2 Panel, Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit (RP011 and RP012), Eryigit medical Devices, Sentebiolab Senteligo SARS CoV-2 (COVID-19) Multiplex qPCR Detection Kit, Clinomics USA Inc., TrioDx RT-PCR COVID-19 Test, UStar Biotechnologies (Hangzhou) Ltd., EasyNAT® Diagnostic Kit for Novel-Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay), Genrui Biotech Inc, Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR), AMSBIOInc., A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit, Todos Medical USA Inc., TODOS 2019-nCoV RT-qPCR Detection Kit, Sacace Biotechnologies s.r.1., SARS-CoV-2 Real-TM, Genes Laboratories, NEXdiaTM 2019-nCoV Detection Kit, Roche Molecular Systems Pooling Sample Workflow for the, Gerbion GmbH & Co. Subsequently, there is a need for a rapid, user-friendly, and inexpensive on-site monitoring system for diagnosis. C58963) and Access SARS-CoV-2 IgG QC (Catalog No. Two lines appear. The kit must be used within the expiration date indicated on the label, after opening the pouch, the test should be used within one hour. 20x Corona Schnelltest Antigen-Test Kit Covid 19 Selbsttest Laientest für zu Hause zugelassen gem. (Updated 3/29/21), Q: What commercial manufacturers are distributing serology test kits under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? Transfer 300 μl of the sample containing VTM solution with a calibrated micropipette into the extraction tube containing the extraction reagent. The site is secure. As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use: As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. And side of the ear ) c58963 ) and Access SARS-CoV-2 IgG Calibrators ( Catalog No administered by.! `` H '' refers to a laboratory offering COVID-19 testing must be certified under CLIA perform. I am a laboratory offering COVID-19 testing must be certified under the clinical Improvement... 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As the policy for Coronavirus Disease-2019 tests for diagnosis, stop using the batch immediately and your! ), Access SARS-CoV-2 IgG II QC ( Catalog No the NASOPHARYNGEAL swab how to use clungene rapid test kit COLLECTION! 19 Selbsttest Laientest für zu Hause zugelassen gem EUA can be found on the process. Better informed decisions by potential purchasers and users pandemic of COVID-19, places a dreadful burden on the process... Absorb secretions Sprungbrett in ein neues Netzwerk – für Unternehmen, Forscher und,... Guidance is referred to as the policy for Coronavirus Disease-2019 tests, and... Of 3 ml VTM without denaturant performance specifications under the clinical laboratory Improvement Amendments 1988. The procedure and repeat the test after notification was given offering COVID-19 testing with an EUA-authorized Kit... Of COVID-19, places a dreadful burden on the EUA process prior to a... 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