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BTK-H2201
BioTeke
Bio-Self COVID-19 ANTIGEN HOME TEST
EUA Number : EUA220400
(The product is only available in the US)
A.Intended Use
The Bio-Self™COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal(nares) swab samples from individuals aged 2 years or older.This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests and for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests.
B. Advantage&Features
1. Sensitivity :96.2%
2. The pathogen can be detected at the initial stage of infection.
3. Short TAT and simple operation.
4. No professional technicians and equipment are required, and the test can be completed in 15 min.
5. Home use.
6. Personal test.
7.Safe for individuals aged 2 years or older
C. Specification
| Package Specification | Test card | Sample tube | Tube cap | Anterior nasal swab | Waste bag | User Manual |
| 1 test/kit | 1 | 1 | 1 | 1 | 1 | 1 |
| 2 tests/kit | 2 | 2 | 2 | 2 | 2 | 1 |
| 5 tests/kit | 5 | 5 | 5 | 5 | 5 | 1 |
| 20 tests/kit | 20 | 20 | 20 | 20 | 20 | 1 |
D. Operation Process
Unpack components ,and place on a flat,clean surface.
E.Result Read
F. Product Qualification（by Sept.13th,2023）
| COVID-19 Antigen Home Test 新型冠状病毒抗原检测试剂盒 自测版 | |
| EUA Certificate | EUA 证书 |
| ISO 13485 Certificate | ISO 13485 证书 |
| ISO 9001 Certificate | ISO 9001 证书 |
| ISO 45001 Certificate | ISO 45001职业健康安全管理体系认证证书 |
| ISO 14001 Certificate | 环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
Bio-Self COVID-19 ANTIGEN HOME TEST
EUA Number : EUA220400
(The product is only available in the US)
A.Intended Use
The Bio-Self™COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal(nares) swab samples from individuals aged 2 years or older.This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests and for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests.
B. Advantage&Features
1. Sensitivity :96.2%
2. The pathogen can be detected at the initial stage of infection.
3. Short TAT and simple operation.
4. No professional technicians and equipment are required, and the test can be completed in 15 min.
5. Home use.
6. Personal test.
7.Safe for individuals aged 2 years or older
C. Specification
| Package Specification | Test card | Sample tube | Tube cap | Anterior nasal swab | Waste bag | User Manual |
| 1 test/kit | 1 | 1 | 1 | 1 | 1 | 1 |
| 2 tests/kit | 2 | 2 | 2 | 2 | 2 | 1 |
| 5 tests/kit | 5 | 5 | 5 | 5 | 5 | 1 |
| 20 tests/kit | 20 | 20 | 20 | 20 | 20 | 1 |
D. Operation Process
Unpack components ,and place on a flat,clean surface.
E.Result Read
F. Product Qualification（by Sept.13th,2023）
| COVID-19 Antigen Home Test 新型冠状病毒抗原检测试剂盒 自测版 | |
| EUA Certificate | EUA 证书 |
| ISO 13485 Certificate | ISO 13485 证书 |
| ISO 9001 Certificate | ISO 9001 证书 |
| ISO 45001 Certificate | ISO 45001职业健康安全管理体系认证证书 |
| ISO 14001 Certificate | 环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
