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
OSANG HEALTHCARE CO., Ltd
South Korea
- Verified Certificate
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16
| 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
-
B2B Trade
| 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
-
16
- 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
Germany
Greece
India
Indonesia
Iran
Italy
U.A.E.
U.S.A
Viet Nam
Yemen
- Factory Information
-
Osang Healthcare
- Main Product
- Attached File
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