GeneFinder™ COVID-19 Ag Self Test

GeneFinder™ COVID-19 Ag Self Testis a rapid chromatographic immunoassay for the qualitative detection of SARS‑CoV‑2 nucleocapsid antigen present


Negotiable Min Order Quantity Unit

Required Quantity
Place of Origin
South Korea
Payment Terms
T/T
Production method
ODM,OEM
Shipping / Lead Time
Negotiable / Negotiable
Keyword
antigen, diagnostics kit, home use, covid-19
Category
Medical Test Kit
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OSANG HEALTHCARE CO., Ltd

Membership
VIP
Country / Year Established
South Korea South Korea / 1996
Business type
Manufacturer
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Product name GeneFinder™ COVID-19 Ag Self Test Certification FDA , CE
Category Medical Test Kit Material -
Keyword antigen , diagnostics kit , home use , covid-19 Unit Size -
Brand name - Unit Weigh -
origin South Korea Stock 100000
Supply type ODM,OEM HS code -

Product Information

 

The “GeneFinder™ COVID-19 Ag Self Test” is intended for non-prescription self-use and as applicable, for an adult lay user testing or another aged 2 years or older. The “GeneFinder™ COVID-19 Ag Self Test” is designed for individuals with symptoms of COVID-19 within the first 7 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. Those who are suspected infectious COVID-19 should perform the test at least twice over three days using “GeneFinder™ COVID-19 Ag Self Test” to detect the SARS CoV-2 antigen as quickly as possible.

 

Clinical Performance

 

In European single site and prospective way, 177 non-professionals(lay-users) performed the evaluation of “GeneFinder™ COVID-19 Ag Self Test” for clinical performance in comparison with professional reference assay (RT-PCR) result.

 

- Positive Percent Agreement (Sensitivity): 96.67% (95% CI: 88.47% – 99.59%)

- Negative Percent Agreement (Specificity): 100.00% (95% CI: 96.60% – 100.00%)

- Positive Predict Value (PPV): 100.00% (95% CI: 88.30% – 100.00%)

- Negative Predict Value (NPV): 98.32% (95% CI: 93.74% – 99.56%)

- Overall Percent Agreement: 98.87% (95% CI:95.98%-99.86%)

 

Verified Certificate

FDA

CE

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Price (FOB) Negotiable transportation Air Transportation,Express,Land Transportation,Negotiation Other,Ocean Shipping
MOQ Negotiable Leadtime Negotiable
Payment Options T/T Shipping time Negotiable

OSANG HEALTHCARE CO., Ltd

Country / Year Established
South Korea South Korea / 1996
Membership
VIP
Business type
Manufacturer

16

TRADE TOWER

DUNS

GMP

ISO

President
SeunEuk Hong
Address
132 Anyangcheondong-ro, Dongan-Gu, Dongan-gu, Anyang-si, Gyeonggi-do, Korea
Product Category
Medical Test Kit
Year Established
1996
No. of Total Employees
101-500
Company introduction

OSANG Healthcare has been a leader in the Korean IVD (In-Vitro Diagnosis) industry since its founding in 1996, ever expanding a wide array of medical devices for biochemical, immunoassay, molecular diagnostics, and digital healthcare.

 

OSANG Healthcare Co., was the first South Korean SARS CoV 2 test kit producer to receive authorization from the U.S. Food & Drug Administration in April 2020.

 

The company has supplied countries all over the world and has already sold 760,000 tests to US customers, including the Federal Emergency Management Agency, Agency (FEMA). Giving the first priority to our customers and partners, we will further develop powerful synergies with other affiliates in the group.

Main Markets

China China

Germany Germany

Greece Greece

India India

Indonesia Indonesia

Iran Iran

Italy Italy

U.A.E. U.A.E.

U.S.A U.S.A

Viet Nam Viet Nam

Yemen Yemen

Factory Information

Osang Healthcare

Main Product
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