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Hangzhou Aichek Medical Technology Co.,Ltd

City:hangzhou

Province/State:zhejiang

Country/Region:china

Contact Person:MrEdward YU

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ISO13485 Antigen Rapid Detection Kit COVID19 15 Min Self Test

Name: ISO13485 Antigen Rapid Detection Kit COVID19 15 Min Self Test
Brand: Aichek
Price: 1 USD

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Brand Name :Aichek

Model Number :COVID-19-G02001A

Certification :CE

Place of Origin :China

MOQ :5000 Test

Price :negotiable

Payment Terms :T/T

Supply Ability :negotiable

Packaging Details :40box/carton

Storage :2℃-30℃

User :Professional

Accuracy :99.05% (95% CI: 97.58%~99.63%)

Certificate :CE ISO 13485

Key words :ISO13485 COVID-19 Antigen Rapid Detection Kit 15 Min Antigen Self Test

OEM :OEM customized packing avaliable

Formats :25T/box 1T/box

Sample :Swab

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ISO13485 COVID-19 Antigen Rapid Detection Kit 15 Min Antigen Self Testt

Product Name	ISO13485 COVID-19 Antigen Rapid Detection Kit 15 Min Antigen Self Test
Formats	Device(4mm)
Place of Origen	China
Specimen	Swab
Read Time	15 minutes
Shelf life	2 years
Package	25 device/box or 1Test/Box
Storage	2℃-30℃

The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab. It provides an aid in the diagnosis of infection with 2019-nCOV.

Intend Use

It's a qualitative detection
specimen sample is nasal swab
The test result can be used for early isolation of patients with suspected infection
To be notic, the result cannot be used as only diagnosis basis of SARS-CoV-2 infection
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment.
Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative

Warning

This kit is a qualitative detection, which cannot determine the exact content of antigen.
The test is intended for use outside the body only.
Not to be taken internally. Avoid sample buffer contact with skin and eyes.
Keep out of the reach of children. Any child under age 18 shouldn’t perform the test without parental guidance, or professional aid.
Not following the exact instructions can affect the outcome of the test. The final diagnosis must be confirmed by a physician.
Do not use the test if the packaging is damaged. Do not use broken test components.