2A8FMU20252EasyNAT COVID-19 RNA Test

>>>3 >>>2>>>1 [PRODUCT NAME] EasyNAT COVID-19 RNA Test [PACKING SPECIFICATION] IVD [INTENDED USE] The EasyNAT COVID-19 RNA Test is a single-use test kit intended to detect SARS -CoV-2 that causes COVID-19. This test is for home use with self-collected anterior nasal swab specimens in individuals aged 14 years and older (self-collected) or individuals aged 2~13 years (collected by an adult) with suspected COVID-19. The assay is only used for auxiliary diagnosis of SARS-CoV-2 infection. This assay applies isothermal amplification and the nucleic acid lateral flow assay to detect and identify specific sequences of SARS-CoV-2 RNA. This assay is similar to a PCR test in that it utilizes a molecular amplification technology for the detection of SARS-CoV-2 viral RNA. SARS-CoV-2 viral RNA is generally detectable in anterior nasal swab specimens during the acute phase of infection. In general, in vitro testing for SARS-CoV-2 infection is most accurate in the first week after symptom onset. Individuals diagnosed with COVID-19 within 3 months are recommended to first seek medical advice of testing because SARS-CoV-2 RNA is detectable in upper respiratory tract specimens even for weeks after the onset of symptoms. Persons who test positive with the EasyNAT COVID-19 RNA Test should seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary. Positive results do not rule out bacterial infection or co-infec- tion with other viruses. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. COVID-19 is an acute respiratory infectious disease. All individuals infected COVID-19 are a source of infection. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. It is difficult to differentiate between COVID-19 and respiratory infections caused by other pathogens through clinical manifestations because the symptoms of respiratory infections caused by these pathogens are similar. Results of the assay are for clinical reference only, and shall not be used as the sole basis for diagnosing or excluding cases. 1 REF U20252 [TEST PRINCIPLE] The assay applies cross priming amplification (CPA) and nucleic acid lateral flow to qualitatively detect the specific sequence of SARS-CoV-2 RNA (genes ORF1ab and N). With the self-driven heating module, the assay can perform isothermal amplification reactions through specific amplification primers, probes, RNA reverse transcriptase, and DNA polymerase with high strand displacement activity. The viral RNA was first transferred to DNA with RNA reverse transcriptase and then amplified with DNA polymerase. The assay consists of a module preloaded with nucleic acid amplification reagent and corresponding lateral flow strip. The paper strip is used for rapid detection of nucleic acid amplification products by [MATERIALS PROVIDED] Materials Provided Disposable sampling swab Sample tube (Prefilled with lysis buffer) Dripper Buffer A (Prefilled in bubbles) Test cassette Zip-lock bag No. 1 2 3 4 5 6 Quantity 1 1 1 2 1 1 chromatographic double antibody sandwich method. Biotin and FAM probe are modified at both ends of one specific primer in the reaction system. For positive samples, due to capillary forces, reported nucleic acid fragment flow from sample pad side to detection pad, then the FAM end of nucleic acid will combine with colloidal gold particles and binds specifically to the T-line with secondary antibody. In the process of chromatography, the other end is captured by streptavidin (line C), so line C with T line color at the same time. For negative samples, only one end of modified biotin is captured by streptavidin (line C) during chromatography, so only C line is colored. If there is an operation error, only T, or both T and C are not colored, the result is regarded as invalid. Note: 1. Do not mix materials from different lots. 2. Do not reuse the materials of the assay. [STORAGE CONDITIONS & VALIDITY PERIOD] 1.Usage: the kit should be used at 2~30°C. 2.Storage: the kit should be stored at 2~8°C. 3.Validity period: 6 months. Refer to the package for the production date and expiry date. 4.Transportation: The kit performance will not be affected by temperature 2~30°C transpor- tation within 15 days. [SAMPLE COLLECTION AND HANDLING] 1. Sample types: anterior nasal swabs 2. Sample storage The samples should be sent for testing as soon as possible after collection. [TEST PROCEDURE] Note: Read this IFU carefully before using. 1. Prepare for test  样本袋 SPECIMEN BAG Disposable sampling swab Buffer A Sample tube Dripper Test cassetteZip-lock bag -Take out all components from the package. 2. Tear off the seal of the sample tube. 3. Swab Both Nostrils 5~10x -Take out the swab and hold with handle end. -Tilt head back and gently insert swab tip（about 18mm） until it is fully inside your nostril. -Roll the swab tip 5~10 times around the inside walls of your nostril. -The swab tip should be touching the walls of the nostril as you rotate. -Repeat swab step in the other nostril. Insert swab into the sample tube and make sure the swab tip is fully immersed in the lysis buffer. -Stir the swab and press the tube bottom for 15 times to release the sample fully. -Dispose of the swab into the ziplock bag. -Put on the dripper. 15x 4. Load Sample and Run Test -Take out the test cassette and place it on a clean flat surface with the side of sample hole facing up. -Open the cap of sample hole. -Press the sample tube lightly to add only one drop lysis buffer into the sample hole. -Open one bubble of buffer A and add all of it into the sample hole. -Pu…

Text truncated - open the document above for the full version.

UstarBiotechnologies(Hangzhou)Ltd. FederalCommunicationsCommission 7435OaklandMillsRoad ColumbiaMD21046 Subject:RequestforConfidentiality FCCID:2A8FMU20252 ToWhomItMayConcern: PursuanttotheprovisionsofSections0.457and0.459oftheCommission’srules(47CFR§§ 0.457,0.459),wearerequestingtheCommissiontowithholdthefollowingattachmentsas confidentialdocumentfrompublicdisclosureindefinitely. SchematicDiagram BlockDiagram TheoryofOperation Abovementioneddocumentcontainsdetailedsystemandequipmentdescriptionareconsidered asproprietaryinformationinoperationoftheequipment.Thepublicdisclosureofabove documentsmightbeharmfultoourcompanyandwouldgivecompetitoranunfairadvantagein themarket. Itisourunderstandingthatallmeasurementtestreports,FCCIDlabelformatandcorrespondent duringcertificationreviewprocesscannotbegrantedasconfidentialdocumentsandthose informationwillbeavailableforpublicreviewoncethegrantofequipmentauthorizationis issued. BestRegards CompanyName:UstarBiotechnologies(Hangzhou)Ltd. ContactName:HongfengZhang TitleofPerson:RegistrationManager Address:6/F,Building2,611DongguanRoad,BinjiangDistrict,Hangzhou,Zhejiang,310053China Date:August25,2022

External Photographs Page 2 of 5 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. . View of EUT-1 View of EUT-2 Page 3 of 5 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. . View of EUT-3 Page 4 of 5 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. . View of EUT-4 View of EUT-5 Page 5 of 5 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. . View of EUT-6 View of EUT-7

Note: 1. The label will attached to the back of the device. 2. This would be a plastic label with a permanent adhesive.

Internal Photographs Page 2 of 3 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. . Internal View of EUT-1 Internal View of EUT-2 Page 3 of 3 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. . Internal View of EUT-3

The results reported herein have been performed in accordance with the laboratory’s terms of accreditation. This report shall not be reproduced except in full without the written approval of the Laboratory. The results in this report apply to the test sample(s) mentioned above at the time of the testing period only and are not to be used to indicate applicability to other similar products. FCC Part15, Subpart B TEST REPORT For EasyNAT COVID-19 RNA Test MODEL NUMBER: U20252 FCC ID: 2A8FMU20252 REPORT NUMBER: 4790487153-1 ISSUE DATE: August 18, 2022 Prepared for Ustar Biotechnologies (Hangzhou) Ltd. 6/F, Building2, 611 Dongguan Road, Binjiang District, Hangzhou, Zhejiang, China Prepared by UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch Building 10, Innovation Technology Park, No. 1, Li Bin Road, Song Shan Lake Hi- Tech Development Zone Dongguan, 523808, People’s Republic of China Tel: +86 769 22038881 Fax: +86 769 33244054 Website: www.ul.com REPORT NO.: 4790487153-1 Page 2 of 19 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch FORM NO: 10-SL-F0035 This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Revision History Rev. Issue Date Revisions Revised By V0 8/18/2022 Initial Issue REPORT NO.: 4790487153-1 Page 3 of 19 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch FORM NO: 10-SL-F0035 This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Summary of Test Results Standard Test Item Limit Result Remark FCC Part15, Subpart B ANSI C63.4-2014 Conducted Disturbance Class B PASS NOTE (2) Radiated Disturbance below 1 GHz Class B PASS Radiated Disturbance above 1 GHz Class B N/A NOTE (1) NOTE (3) Note: (1) “N/A” denotes test is not applicable in this test report. (2) This test is only applicable for devices which can be charged or powered by AC power cable. (3) If the highest frequency of the internal sources of the EUT is less than 108 MHz, the measurement shall only be made up to 1 GHz. If the highest frequency of the internal sources of the EUT is between 108 MHz and 500 MHz, the measurement shall only be made up to 2 GHz. If the highest frequency of the internal sources of the EUT is between 500 MHz and 1 GHz, measurement shall only be made up to 5 GHz. If the highest frequency of the internal sources of the EUT is above 1 GHz, the measurement shall be made up to 5 times the highest frequency or 40 GHz, whichever is less. (4) This test report is only published to and used by the applicant, and it is not for evidence purpose in China. (5) The measurement result for the sample received is <Pass> according to < FCC Part15, Subpart B > when <Accuracy Method> decision rule is applied. REPORT NO.: 4790487153-1 Page 4 of 19 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch FORM NO: 10-SL-F0035 This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. CONTENTS 1. ATTESTATION OF TEST RESULTS ..................................................................................... 5 2. TEST METHODOLOGY ......................................................................................................... 6 3. FACILITIES AND ACCREDITATION ..................................................................................... 6 4. CALIBRATION AND UNCERTAINTY ................................................................................... 7 4.1. MEASURING INSTRUMENT CALIBRATION ........................................................... 7 4.2. MEASUREMENT UNCERTAINTY ............................................................................ 7 5. EQUIPMENT UNDER TEST .................................................................................................. 8 5.1. DESCRIPTION OF EUT ........................................................................................... 8 5.2. TEST MODE ............................................................................................................. 8 5.3. EUT ACCESSORY ................................................................................................... 8 5.4. SUPPORT UNITS FOR SYSTEM TEST ................................................................... 8 6. MEASURING EQUIPMENT AND SOFTWARE USED........................................................... 9 7. EMISSION TEST ................................................................................................................. 10 7.1. CONDUCTED EMISSIONS MEASUREMENT ........................................................ 10 7.2. RADIATED EMISSIONS MEASUREMENT ............................................................. 14 REPORT NO.: 4790487153-1 Page 5 of 19 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch FORM NO: 10-SL-F0035 This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. 1. ATTESTATION OF TEST RESULTS Applicant Information Company Name: Ustar Biotechnologies (Hangzhou) Ltd. Address: 6/F, Building2, 611 Dongguan Road, Binjiang District, Hangzhou, Zhejiang, China Manufacturer Information Company Name: Ustar Biotechnologies (Hangzhou) Ltd. Address: 6/F, Building2, 611 Dongguan Road, Binjiang District, Hangzhou, Zhejiang, China EUT Information EUT Name: EasyNAT COVID-19 RNA Test Model Name: U20252 Sample Received Date: August 10, 2022 Sample Status: Normal Sample ID: 5228527-1 Date of Tested: August 10, 2022 ~ August 18, 2022 APPLICABLE STANDARDS STANDARD TEST RESULTS FCC Part15, Subpart B PASS Prepared By: Checked By: Andy Wan Denny Huang Project Engineer Senior Project Engineer Approved By: Stephen Guo Laboratory Manager REPORT NO.: 4790487153-1 Page 6 of 19 UL Verification Servi…

Text truncated - open the document above for the full version.

APPENDIX I Setup Photographs Conducted Emission Test Setup Photo 9KHz-30MHz Radiated Emission Test Setup Photo 30MHz-1GHz Radiated Emission Test Setup Photo