China Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) K601416D (For sell in Thailand, specially only for Thailand) manufacturers and suppliers | Realy

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Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) K601416D (For sell in Thailand, specially only for Thailand)

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) K601416D (For sell in Thailand, specially only for Thailand) Featured Image

Short Description:

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) is an in vitro diagnostic test for the qualitative detection Nucleoprotein of Coronavirus Disease 2019 in human nasal swab, using the rapid immunochromatographic method as an aid in the diagnosis of SARS-Cov-2 infections. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. It will provide information for clinical doctors to prescribe correct medications.

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【FEATURES】

·Specimen type:?Nasal Swab

·Testing time:?10-15 minutes

·Sensitivity:?95.38%

·Specificity:?>99.9%

【DIRECTIONS FOR USE】

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(Nasal Swab) DIMDI registration for SARS-Cov-2 antigen rapid test kits

3.1 (Nasal Swab) DIMDI registration for SARS-Cov-2 antigen rapid test kits_00

3.1 (Nasal Swab) DIMDI registration for SARS-Cov-2 antigen rapid test kits_01

3.1 (Nasal Swab) DIMDI registration for SARS-Cov-2 antigen rapid test kits_02

3.1 (Nasal Swab) DIMDI registration for SARS-Cov-2 antigen rapid test kits_03

3.1 (Nasal Swab) DIMDI registration for SARS-Cov-2 antigen rapid test kits_04

ISO 13485 EN 1056?Hangzhou?Realy?Q5?0002?Rev?02

3.2 ISO 13485 EN 1056?Hangzhou?Realy?Q5?0002?Rev?02_00

3.2 ISO 13485 EN 1056?Hangzhou?Realy?Q5?0002?Rev?02_01

(nasal swab) Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device DOC

3.3 (nasal swab) Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device DOC_00

ARTG Certificate 334501 - Updated inclusion Rapid Antigen Cassette -TGA

ARTG Certificate 334501 - Updated inclusion Rapid Antigen Cassette -TGA_00

ARTG Certificate 334501 - Updated inclusion Rapid Antigen Cassette -TGA_01

EUA210482-?Acknowledgement?Letter

EUA210482-?Acknowledgement?Letter_00

MX39@SSET6YTKWM1LKR51

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