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Antigen Test for COVID-2019
The SARS-CoV-2 Antigen Rapid Test Kit from Lepu Medical employs colloidal gold immunochromatography for the qualitative detection of COVID-19 antigens in nasal or nasopharyngeal swab samples. It uses gold-labeled SARS-CoV-2 N protein monoclonal antibodies pre-coated on the bonding pad, with paired antibodies fixed in the test and control lines. This kit delivers results in 15-30 minutes, making it suitable for point-of-care screening in clinical laboratories, hospitals, and field environments.
The test is designed to detect the virus from the early phase of infection, as early as 2-3 days before symptom onset, through to the late phase, up to 7-10 days after symptom onset. It meets the minimum criteria for antigen tests as evaluated by the Paul Ehrlich Institute (PEI) in consultation with Germany’s Robert Koch-Institut (RKI). The kit is distributed in a card-like format, requiring no additional devices for operation.
Primary buyers include clinical laboratories, hospitals, and government agencies running high-throughput screening programs. The product is available in bulk packaging with accessories for large-scale testing initiatives. Lepu Medical ensures compliance with cold-chain requirements and provides export documentation for international trade, with destination country IVD registration required for import.
| Test Method | Colloidal gold immunochromatography |
| Target Antigen | SARS-CoV-2 N protein |
| Sample Type | Nasal or nasopharyngeal swab |
| Result Time | 15-30 minutes |
| Detection Window | 2-3 days pre-symptom to 7-10 days post-symptom |
| Approval Body | German PEI and RKI |
| Regulatory Mark | CE under IVD regulations |
| Typical Sensitivity | Meets PEI minimum criteria for antigen tests |
| Typical Specificity | Meets PEI minimum criteria for antigen tests |
| Storage Temperature | 2-30°C |
| Typical Shelf Life | 18 months typical |
Lepu Medical is based in Shenzhen, China, at Floor 5, Building 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District. The company holds a harbor trust tier, indicating a verified operational presence. Lepu Medical specializes in the development and export of in vitro diagnostic devices, including rapid test kits for infectious diseases.
The supplier’s focus includes regulated medical diagnostics for international markets, with products designed to meet stringent global standards. Lepu Medical’s SARS-CoV-2 Antigen Rapid Test Kit has been recognized by German authorities for its performance, fulfilling PEI and RKI criteria for antigen testing. The company supports bulk procurement and provides the necessary documentation for export compliance.
This SARS-CoV-2 Antigen Rapid Test Kit employs colloidal gold immunochromatography for qualitative detection of COVID-19 antigens from nasal or nasopharyngeal swab samples. Designed for point-of-care use with rapid 15-30 minute results, the kit is suitable for screening in clinical laboratories, hospitals, and field testing environments. As a regulated in vitro diagnostic device, it requires appropriate export documentation, cold-chain compliance, and destination country IVD registration for international trade. Available in bulk packaging with accessories for high-throughput screening programs.
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Sourcing Antigen Test for COVID-2019 from Lepu Medical - China Import Guide
Before placing an order, verify that the SARS-CoV-2 Antigen Rapid Test Kit complies with your country’s IVD regulations. Request the PEI and RKI validation reports, as well as CE marking documentation, to ensure the product meets local standards. Lepu Medical can provide these certificates for your review and import approval process.
Discuss logistics with Lepu Medical to confirm cold-chain requirements, as some countries mandate temperature-controlled shipping for diagnostic kits. Agree on Incoterms such as FOB Shenzhen or CIF to your port, and clarify payment terms like TT or LC. Lead times for bulk orders should be confirmed, as production and shipping schedules may vary based on demand.
Upon arrival, conduct quality checks to ensure the kits are within their typical 18-month shelf life and free from damage. Request a certificate of conformity to verify compliance with EU and German standards. For large shipments, consider third-party inspection to validate sensitivity and specificity performance. Maintain all documentation for regulatory compliance and traceability.
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30 suppliersBuy Antigen Test For Covid-20 in Bulk — Supplier in China
When sourcing Antigen Test For Covid-2019 for your business, securing the right balance of quality and cost is essential. Lepu Medical, a supplier based in China, offers this product with key specifications including In Vitro Diagnostic (IVD) / Point-of-Care Testing (POCT), Colloidal Gold Immunochromatographic Lateral Flow, and Nasopharyngeal or Nasal Swab. By purchasing directly from the manufacturer or authorized exporter, buyers can negotiate favorable FOB prices starting at $3.00 – $15.00 / Test Kit and manage bulk orders with a minimum order quantity (MOQ) of 1 Bags. This product is actively traded under HS Code 3822.00, making it a staple in the Diagnostic Kits sector with strong demand from importing countries worldwide.
Antigen Test For Covid-20 Specifications, Trade Terms & Pricing
Importing Antigen Test For Covid-20 requires careful attention to shipping logistics, customs compliance, and secure payment terms. Lepu Medical offers flexible shipping options such as Full Container Load (FCL) or Less than Container Load (LCL) via sea freight. To ensure a smooth transaction, buyers should verify import duties for HS Code 3822.00 in their destination country. Common payment methods for international B2B transactions include Letter of Credit (L/C), Telegraphic Transfer (T/T), and Documents against Payment (D/P). All transactions and RFQs are facilitated through EximNext, a leading online B2B marketplace designed to make cross-border trade secure and efficient.
About Lepu Medical — Supplier in China
Finding trustworthy partners is the foundation of successful importing. Ask the supplier of this Antigen Test For Covid-20 for business registration and quality documents before ordering. Whether you are a distributor, wholesaler, or procurement manager, you can request a free quotation, ask for product samples, and finalize your bulk purchase with confidence. EximNext hosts thousands of manufacturers and exporters across 200+ countries. Explore similar products in the Diagnostic Kits category and connect with top-tier exporters on our comprehensive B2B marketplace. Start your sourcing journey today.
Import Antigen Test For Covid-20 — Shipping, Logistics & Customs
Importing Antigen Test For Covid-20 requires careful attention to shipping logistics, customs compliance, and secure payment terms. Common shipping options include Full Container Load (FCL) or Less than Container Load (LCL) via sea freight. Buyers should verify import duties for HS Code 3822.00 in their destination country. Common payment methods include Letter of Credit (L/C), Telegraphic Transfer (T/T), and Documents against Payment (D/P).
Frequently Asked Questions About Antigen Test For Covid-20
What is the wholesale price of Antigen Test For Covid-2019?
The current listed wholesale price for Antigen Test For Covid-2019 from Lepu Medical is $3.00 – $15.00 / Test Kit on FOB terms from China. Prices may vary depending on order volume, packaging, and destination. For the most accurate bulk quote, send a direct RFQ to Lepu Medical through EximNext.
What is the Minimum Order Quantity (MOQ) for Antigen Test For Covid-20?
The supplier, Lepu Medical, has set a Minimum Order Quantity (MOQ) of 1 Bags for Antigen Test For Covid-20. For sample requests or smaller trial orders, contact the supplier directly through our platform's inquiry system.
What is the HS Code for Antigen Test For Covid-2019?
For international shipping and customs clearance, Antigen Test For Covid-2019 is classified under HS Code 3822.00. Buyers should verify their local customs regulations to determine applicable import duties and taxes for this classification.
How can I import Antigen Test For Covid-20 from China?
To import Antigen Test For Covid-20 from China, negotiate shipping terms (FOB, CIF, or EXW) directly with Lepu Medical. Ensure you have the necessary import licenses for Diagnostic Kits products in your destination country.
How can I check Lepu Medical before ordering?
Open the Lepu Medical company profile on EximNext to see the details the company has provided. Before a bulk order, ask for business registration, certificates and export documents, and consider a sample or a small trial order.
What are the key specifications of Antigen Test For Covid-2019?
The key specifications for Antigen Test For Covid-2019 supplied by Lepu Medical include In Vitro Diagnostic (IVD) / Point-of-Care Testing (POCT), Colloidal Gold Immunochromatographic Lateral Flow, and Nasopharyngeal or Nasal Swab. For a complete technical data sheet or Certificate of Analysis (COA), send an inquiry directly to the supplier through EximNext.
What packaging options are available for bulk orders of Antigen Test For Covid-20?
Lepu Medical offers Antigen Test For Covid-20 with standard export packaging. Custom packaging, private labeling, and OEM/ODM options may also be available for large wholesale orders.
Which countries import Antigen Test For Covid-20 the most?
Antigen Test For Covid-20 is actively imported by buyers worldwide. Request a destination-specific CIF or CFR quote from Lepu Medical through our platform.
What certifications does this Antigen Test For Covid-20 supplier hold?
Lepu Medical maintains international quality certifications. These ensure that the Antigen Test For Covid-20 meets international quality, safety, and regulatory standards required for cross-border trade.
How do I place a bulk order for Antigen Test For Covid-2019 on EximNext?
Click "Request Quotation" on this product page, specify your required quantity, preferred shipping terms, and destination country. Lepu Medical will respond with a detailed wholesale quote including FOB pricing, lead time, and payment options.
What payment methods are accepted?
Common payment methods include Letter of Credit (L/C), Telegraphic Transfer (T/T), Documents against Payment (D/P), and Escrow services. Confirm accepted terms directly with Lepu Medical.
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