Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd

Manufacturer from China
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ISO13485 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy

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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 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy

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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 :CE SARS-CoV-2 Professional Antigen Rapid Test Kit IVD Swab Type
OEM :OEM customized packing avaliable
Formats :25T/box 1T/box
Sample :Swab
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CE SARS-CoV-2 Professional Antigen Rapid Test Kit IVD Swab Type

Product Name

CE SARS-CoV-2 Professional Antigen Rapid Test Kit IVD Swab Type

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℃

Intend Use
The SARS-CoV-2 antigen rapid test kit is intended for professional detection sars-cov-2 antigen in infection human nasopharyngeal or oropharyngeal swab, the test provides preliminary test results. It's an aid inthe diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. To be attention the test result should no be used as the sole basis for diagnosis.

PRINCIPLE
The Device uses the principle of the double antibody sandwich method for detecting the nucleoprotein (N) of SARS-CoV-2. The marker is composed of the anti-N antibody 1 labeled with colored particles. When testing, the sample was added into the sample well and migrated to the absorbent pad by the capillary effect. If the virus exists, it will react with the marker and captured by the anti-N antibody 2 coated in the NC membrane. Then there is a colored line produced at the test area, indicating a positive result. If there is no virus in the sample, the colored line will not show at the test area and it means a negative result. Regardless of whether the virus contained in the sample, as a procedural control, a colored line will always appear at the control area, indicating that proper volume of specimen has been added and the correct test procedure is conducted.

ISO13485 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy

ISO13485 Swab One Step Rapid Test IVD Test Kit 99.05% Accuracy

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