2AWR4ISRSC01Electronic rapid diagnostic test for self-diagnosis of COVID-19 in an at home scenario.

Before you start During the testAfter the test When to use this kit PRODUCT INFORMATION LEAFLET Refer to the Quick Start Guide for a summary of the key information of this leaflet. General Information Please read this leaflet before using the test. You should follow the Ellume COVID-19 Home Test App when performing the test. The test is intended to be used as an aid in the diagnosis of a current COVID-19 infection. Please consult a healthcare professional to discuss your results and if additional testing is necessary. Use this test: As an aid in the diagnosis of current COVID-19 infection AND; If you are concerned that you have COVID-19. Do not use this test: On anyone under 2 years of age; If you are prone to nosebleeds, OR; If you have had a facial or head injury/ surgery in the last 6 months. COVID-19 Home Test – What is included in the Box Nasal Swab with Child Adapter Product Information Leaflet and Quick Start Guide are also included. Flip-top Lid Child Adapter Tab Processing Fluid 1 23 Swab Tip Dropper www.ellumecovidtest.com Preparing to do the test Ensure you have an internet connection to download the App. Features like emailing of test result record and result sharing also require an internet connection. Ensure you are using a compatible smartphone. For a full list of compatible devices visit: www.ellumecovidtest.com Ensure your phone is charged (at least 20% battery) or is charging. Ensure your test is at room temperature 59-77°F (15-25°C). Ensure all packaging is intact. Do not use the test if there is visible damage to the foil packaging. Only open the foil packaging when you are ready to do the test. Use test within 1 hour after opening. Wash your hands with soap and water or use hand sanitizer before using the test. Keep the Swab clean. Avoid touching the Swab Tip and ensure it does not touch any surfaces before use. Step-By-Step Instructions This leaflet only describes the key steps of the test. Step-by-step instructions on how to perform this test are in the Ellume COVID-19 Home Test App. 1 Unbox components Only open foil packaging when you are ready to do the test. Use within 1 hour after opening. 2 Download and open App Find the free Ellume COVID-19 Home Test App on the Google Play Store, the App Store or use your smartphone’s browser to visit: www.ellumecovidtest.com 3 Answer a few questions in the App This will select the right video and instructions for you and enable health authorities to monitor COVID-19 infection and test positivity rates. 4 Watch info video The video will provide an overview of what to expect. There will be separate step-by-step instructions later in the App. 5 Follow instructions Separate step-by-step instructions will be available within the App after the video. 6 Your test result After finishing the testing process wait 15 minutes for your result to appear on your phone screen. The App will store your result and if selected a test result record will be sent to your email. ButtonSample Port Analyzer Do’s and don’tsCorrect swabbing A positive test result indicates that you very likely currently have COVID-19 disease. COVID-19 is a viral illness that causes multiple symptoms including fever, a cough, sore throat and shortness of breath (refer to COVID-19 information section). What you need to do: 1. Consult a healthcare professional as soon as possible. Please tell them that you tested positive for COVID-19. Provide your healthcare professional with: ‒ Your Test Result Record (sent to you via email and in your COVID-19 Home Test App) ‒ The Product Overview for Healthcare Professionals (in your COVID-19 Home Test App) ‒ The Fact Sheet for Healthcare Professionals (in your COVID-19 Home Test App) If you have no symptoms, particularly if you live in an area with low numbers of COVID-19 infections and have had no exposure to anyone diagnosed with COVID-19, additional molecular testing to confirm your result may be required. Please advise the healthcare professional you have tested positive and have no symptoms. See FAQ ‘Can I have a false positive test result’ on our website http:// ellumecovidtest.com/FAQ. 2. You should self-isolate at home as per CDC recommendations to stop spreading the virus to others. Please consult the CDC recommendations regarding self-isolation www.cdc.gov/ coronavirus. Press the YOUR RESULT & WHAT IT MEANS button on the result screen in the App to find out more about your result and when you can be with others again. A negative test result indicates that you are unlikely to currently have COVID-19 disease. A negative test result means that proteins, small parts of the virus that causes COVID-19, were not found in your sample. However, you may have had COVID-19 previously. To confirm a previous infection, you will need to take a different type of test (antibody test). What you need to do: Please consult a healthcare professional if you develop symptoms, symptoms persist or become more severe. Negative results, particularly if you have no symptoms of COVID-19, may require additional molecular testing to confirm your result. Please see FAQ ‘Can I have a false negative test result’ on our website http://ellumecovidtest. com/FAQ. So, what is making you sick? There are many other viruses that cause similar symptoms to COVID-19 and these may be the cause of your symptoms. Regardless of the test result, it is important that while you are sick you should practice social distancing and good hygiene and should not attend work. If you develop symptoms or your symptoms persist or become more severe, if you are concerned about your health or you develop one of the emergency warning signs (see COVID-19 information section) then you should seek medical attention immediately. Your test has experienced an error. You will need to retest with a new test or consult a healthcare professional. Self-isolate at home. Call the Ellume toll free helpline 1-888-885-6121 and have your test result and test packaging handy. We will need the Error Code, L…

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EMC Technologies Pty Ltd, Unit 3, 87 Station Road, Seven Hills, NSW, 2147, Australia www.emctech.com.au To: Timco Engineering Inc Attention: Certification Officer Date: January 29, 2021 EMC Ref: S201003 Subject: Original Certification (LMA) Company: Ellume Ltd FRN: 0029111911 FCC ID: 2AWR4ISRSC01 EUT: Home COVID (I-SRS-C-01) Ellume Ltd is applying for a certification of the Home COVID (I-SRS-C-01) This application is for FCC Certification. The device is an electronic rapid diagnostic test for self- diagnosis of COVID-19 in an at home scenario. EMC Technologies Pty Ltd is acting as agent for Ellume Ltd in this application. Background information supplied by Ellume Ltd. Ellume has developed the first electronic rapid diagnostic test for self-diagnosis of COVID-19 in an at-home scenario. The FDA has recently granted an Emergency Use Authorisation (EUA) for sale of the product into the USA. In practice, the Ellume product is extremely similar and electrically almost identical, to that lodged for the GSK Theraflu Home Flu Test product (FCC ID: 2ANNMTHFT1) except targeting COVID-19 instead of Influenza. Ellume has been engaged by the National Institute of Health’s RADx (Rapid Acceleration of Diagnostics) program to deliver this test to the US market as soon as possible to aid the US government’s COVID-19 response plan. Please refer to the following link for more information: https://www.nih.gov/news-events/news-releases/nih-funded-covid-19-home-test-first-receive-over- counter-authorization-fda This product is urgently required for the US government’s COVID response plan in order to scale up the testing program and address the COVID-19 pandemic. Should you require any further information, please advise. Best Regards Tracy Newman Quality Manager EMC Technologies Pty Ltd Unit 3, 87 Station Road, Seven Hills, NSW, 2147, Australia Ph. +61 2 9624 2777; www.emctech.com.au EMC Technologies Pty Ltd ABN 82 057 105 549 Unit 3, 87 Station Road, Seven Hills, NSW, 2147 Australia Ph: + +61 2 9624 24777 Email: [email protected]

Page 1 of 6 EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills NSW 2147 Tel: +61 2 9624 2777 Auckland (NZ) 47 MacKelvie Street Grey Lynn Auckland Tel: +64 9 360 0862 APPENDIX B OF TEST REPORT S201003-1 v2 IDENTIFICATION PHOTOGRAPHS OF TEST SAMPLE (EXTERNAL) FCC ID: 2AWR4ISRSC01 Manufacturer: Ellume Ltd Test Sample: Home COVID (I-SRS-C-01) Model Number: I-SRS-C-01 Part Number M1000221 Date: 2 nd February 2021 FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix B – External Photographs v2 Page 2 of 6 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 REVISION TABLE Version Sec/Para Changed Change Made Date 1 Initial issue of document 28/01/2021 2 Appendix B3 – Rear of EUT removed 02/02/2021 Appendix B4 – Rear of EUT added FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix B – External Photographs v2 Page 3 of 6 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 APPENDIX B1 EXTERNAL IDENTIFICATION PHOTOGRAPHS Overall FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix B – External Photographs v2 Page 4 of 6 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 APPENDIX B2 EXTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix B – External Photographs v2 Page 5 of 6 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 APPENDIX B3 EXTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix B – External Photographs v2 Page 6 of 6 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 APPENDIX B4 EXTERNAL IDENTIFICATION PHOTOGRAPHS Label Location

Page 1 of 10 EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills NSW 2147 Tel: +61 2 9624 2777 Auckland (NZ) 47 MacKelvie Street Grey Lynn Auckland Tel: +64 9 360 0862 APPENDIX C OF TEST REPORT S201003-1 v1 IDENTIFICATION PHOTOGRAPHS OF TEST SAMPLE (INTERNAL) FCC ID: 2AWR4ISRSC01 Manufacturer: Ellume Ltd Test Sample: Home COVID (I-SRS-C-01) Model Number: I-SRS-C-01 Part Number M1000221 Date: 28 th January 2021 FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 2 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C1 INTERNAL IDENTIFICATION PHOTOGRAPHS Overall View FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 3 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C2 INTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 4 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C3 INTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 5 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C4 INTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 6 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C5 INTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 7 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C6 INTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 8 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C7 INTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 9 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C8 INTERNAL IDENTIFICATION PHOTOGRAPHS FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix C – Internal Identification Photographs v1 Page 10 of 10 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX C5 INTERNAL IDENTIFICATION PHOTOGRAPHS

Page 1 of 65 EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au Melbourne 176 Harrick Road Keilor Park Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills NSW 2147 Auckland (NZ) 47 MacKelvie Street Grey Lynn Auckland Tel: +64 9 360 0862 RADIO REPORT FOR CERTIFICATION to 47 CFR Part 15 Subpart C (Section 15.247) Report Number: S201003-1 v1 FCC ID: 2AWR4ISRSC01 Tested For: Ellume Ltd Device under Test : Home COVID (I-SRS-C-01) Model Number: I-SRS-C-01 Part Number: M1000221 Issue Date: 28 th January 2021 EMC Technologies Pty Ltd reports apply only to the specific samples tested under stated test conditions. It is the manufacturer’s responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. EMC Technologies Pty Ltd shall have no liability for any deductions, inferences or generalisations drawn by the client or others from EMC Technologies Pty Ltd issued reports. This report shall not be used to claim, constitute or imply product endorsement by EMC Technologies Pty Ltd. FCC ID: 2AWR4ISRSC01 EMC Technologies Pty Ltd Report No. S201003-1 v1 Page 2 of 65 This document shall not be copied or reproduced, except in full. www.emctech.com.au REVISION TABLE Version Sec/Para Changed Change Made Date 1 Initial issue of document 28/01/2021 FCC ID: 2AWR4ISRSC01 EMC Technologies Pty Ltd Report No. S201003-1 v1 Page 3 of 65 This document shall not be copied or reproduced, except in full. www.emctech.com.au RADIO REPORT FOR CERTIFICATION 47 CFR Part 15 Subpart C (Section 15.247) CONTENTS 1.0 INTRODUCTION 2.0 GENERAL INFORMATION 3.0 TEST RESULTS 3.1 §15.203 Antenna Requirement 3.2 §15.204 Antenna Information 3.3 §15.207 Disturbance Voltage on AC Mains 3.4 §15.247(a)(2) 6 dB Bandwidth 3.5 §15.247(e) 3kHz Peak Power Density 3.6 §15.247(b) Peak Output Power 3.7 §15.247(d) Spurious Radiated Emission 3.8 §15.247(d) Out of Band Emissions 3.9 §2.1049 99% Occupied Bandwidth 3.10 §15.247 (i) Maximum Permissible Exposure 4.0 COMPLIANCE STATEMENT 5.0 MEASUREMENT UNCERTAINTY APPENDIX A PHOTOGRAPHS OF TEST SETUP APPENDIX B IDENTIFICATION PHOTOGRAPHS OF TEST SAMPLE (EXTERNAL) APPENDIX C IDENTIFICATION PHOTOGRAPHS OF TEST SAMPLE (INTERNAL) FCC ID: 2AWR4ISRSC01 EMC Technologies Pty Ltd Report No. S201003-1 v1 Page 4 of 65 This document shall not be copied or reproduced, except in full. www.emctech.com.au RADIO REPORT FOR CERTIFICATION Issued by: EMC TECHNOLOGIES PTY. LTD. Unit 3/87 Station Road, Seven Hills, NSW, 2147, Australia Phone: +61 2 9624 2777, E-mail: [email protected] , Web: www.emctech.com.au Product : Home COVID ( I-SRS-C-01) Model Number: I-SRS-C-01 Part Number: M10000221 FCC ID: 2AWR4ISRSC01 Manufacturer: Ellume Ltd 57 Didsbury Street, East Brisbane, QLD, 4169, Australia Tested for: Ellume Ltd Address: 57 Didsbury Street, East Brisbane, QLD, 4169, Australia Phone: +61 417 916 824 Contact: Tim Laing Email: [email protected] Standards: 47 CFR Part 15 – Radio Frequency Devices Subpart C – Intentional Radiators Section 15.247 – Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz Test Dates: 15 th October 2020 to 20 th October 2020 Issue Date: 28 th January 2021 Attestation: I hereby certify that the device(s) described herein were tested as described in this report and that the data included is that which was obtained during such testing. Test Engineer: Dong Feng Authorised Signatory: Quinn Wu Lead Engineer EMC Technologies Pty Ltd. FCC ID: 2AWR4ISRSC01 EMC Technologies Pty Ltd Report No. S201003-1 v1 Page 5 of 65 This document shall not be copied or reproduced, except in full. www.emctech.com.au RADIO REPORT FOR CERTIFICATION to 47 CFR Part 15 Subpart C (section 15.247) 1.0 INTRODUCTION Radio tests were performed on Home COVID (I-SRS-C-01) with Model: I-SRS-C-01, in accordance with the applicable requirements of 47 CFR, Part 15 Subpart C – Section 15.247 operating within the band: 2400 MHz to 2483.5 MHz. 1.1 Test Procedure Radio measurements were performed in accordance with the appropriate procedures of ANSI C63.10: 2013 and KDB 558074 v05r02 - Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) Operating Under §15.247. The measurement instrumentation conformed to the requirements of ANSI C63.2: 2016. 1.2 Summary of 47 CFR Part 15 Subpart C Results FCC Part 15 Subpart C Test Performed Results 15.203 Antenna requirement Complied 15.204 Antenna information Complied 15.205 Restricted bands of operation Complied 15.207 Disturbance voltage on AC Mains Not Applicable EUT is Battery powered 15.247(c) Spurious radiated emission 15.209 limit applied Complied 15.247 (a2) 6 dB Bandwidth Complied 15.247 (e) 3 kHz Peak Power Density Complied 15.247 (b) Peak Output Power Complied 15.247 (c) Antenna Gain > 6 dBi Not Applicable Antenna Gain < 6 dBi 15.247 (d) Out of Band Emissions Complied 15.247 (f) Hybrid Systems Not Applicable 15.247 (i) Radio Frequency Hazard Complied 99% Occupied bandwidth Complied 1.3 Modifications by EMC Technologies No modifications were performed on the EUT in order to achieve compliance. FCC ID: 2AWR4ISRSC01 EMC Technologies Pty Ltd Report No. S201003-1 v1 Page 6 of 65 This document shall not be copied or reproduced, except in full. www.emctech.com.au 2.0 GENERAL INFORMATION 2.1 EUT (Transmitter) Details The Equipment Under Test (EUT) was identified as follows: FCC ID: 2AWR4ISRSC01 Manufacturer: Ellume Ltd Product : Home COVID (I-SRS-C-01) Model Number: I-SRS-C-01 Part Number: M1000221 Microprocessor: Nordic n RF52810 Crystal Frequency: 32MHz Highest Internal Frequency: 2.480GHz Operating Band: 2.400-2.4835GHz ISM band (Bluetooth Low Energy) Nominal Power: 0.1W Antenna type and gain: Microstrip PCB-printed quarter-wave monopole 0 dBi N…

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Page 1 of 5 EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills NSW 2147 Tel: +61 2 9624 2777 Auckland (NZ) 47 MacKelvie Street Grey Lynn Auckland Tel: +64 9 360 0862 APPENDIX A OF TEST REPORT S201003-1 v1 PHOTOGRAPHS OF TEST SET UP FCC ID: 2AWR4ISRSC01 Manufacturer: Ellume Ltd Test Sample: Home COVID (I-SRS-C-01) Model Number: I-SRS-C-01 Part Number: M1000221 Date: 28 th January 2021 FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix A Test Setup Photographs Page 2 of 5 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX A1 TEST SET UP PHOTOGRAPHS Radiated Emission Below 1GHz FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix A Test Setup Photographs Page 3 of 5 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX A2 TEST SET UP PHOTOGRAPHS Radiated Emission Above 1GHz FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix A Test Setup Photographs Page 4 of 5 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX A3 TEST SET UP PHOTOGRAPHS Radiated Emission Above 18GHz FCC ID: 2AWR4ISRSC01 Report No. S201003-1 Appendix A Test Setup Photographs Page 5 of 5 EMC Technologies Pty Ltd Unit 3, 87 Station Road Seven Hills NSW 2147 Australia Tel: +61 2 9624 2777 Fax: +61 2 9838 4050 APPENDIX A4 TEST SET UP PHOTOGRAPHS Peak Power Density