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The Lepu SARS-CoV-2 Antigen Test Kit distributed by Pharmonco Limited is a lateral flow immunochromatographic device for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal swab samples. It uses immunochromatographic assay reagents on a nitrocellulose membrane backing with monoclonal antibody conjugates. This kit has been specially approved by Germany’s BfArM for self-testing and carries CE marking under IVD regulations, validating its compliance for point-of-care and home use in European markets.
The test operates on standard lateral flow principles, with a typical detection sensitivity of 95% and specificity of 99% for SARS-CoV-2 antigens, aligning with EU entry requirements. Packaging includes test cards, swabs, and buffers, with a standard shelf life of 18 months when stored at 2-30°C. The kit is designed for retail and bulk export, supporting high-volume procurement for healthcare distributors and pharmacy chains.
Primary buyers include European healthcare distributors, pharmacy chains, and government procurement agencies sourcing reliable rapid tests for public health programs. The product is shipped from Hong Kong with export documentation and cold-chain compliance where required. Importers should confirm destination country IVD registration and any additional local certification needs before ordering.
| Test Method | Lateral flow immunochromatography |
| Target Antigen | SARS-CoV-2 nucleocapsid protein |
| Sample Type | Nasal swab |
| Approval Body | Germany BfArM |
| Regulatory Mark | CE under IVD regulations |
| Intended Use | Point-of-care and home use |
| Typical Sensitivity | 95% typical for SARS-CoV-2 antigen detection |
| Typical Specificity | 99% typical for SARS-CoV-2 antigen detection |
| Storage Temperature | 2-30°C |
| Typical Shelf Life | 18 months typical |
| Packaging Format | Retail and bulk export kits |
Pharmonco Limited operates from 11g King Palace Plaza, 55 King Yip Street, Kowloon, Hong Kong. The company holds a harbor trust tier on the platform, indicating a verified presence, though its current response rate and average response time are not publicly disclosed. Pharmonco Limited focuses on the distribution of medical diagnostics, including regulated in vitro diagnostic devices for international trade.
The supplier specializes in procuring and exporting approved diagnostic kits, such as the Lepu SARS-CoV-2 Antigen Test Kit, which meets EU market standards. While the profile does not list headcount or revenue, the company’s address and operational focus suggest a dedicated role in connecting international buyers with compliant healthcare products for export.
The Lepu SARS-CoV-2 Antigen Test Kit is a lateral flow immunochromatographic in-vitro diagnostic designed for the qualitative detection of SARS-CoV-2 nucleocapsid antigen from nasal swab samples. Approved by Germany's BfArM for self-testing and CE marked under IVD regulations, it is suitable for point-of-care and home use applications. Packaged for retail and bulk export, this kit meets the standard sensitivity and specificity thresholds required for EU market entry, making it a reliable procurement option for importers serving European healthcare distributors and pharmacy chains.
| Business Type | Supplier |
| Year Established | Recently Joined |
| Employees | Contact Supplier |
| Annual Revenue | Contact Supplier |
| Main Products | View Products Tab |
| Major Markets | Global |
| Response Time | <4h |
| Response Rate | New Supplier |
Before ordering, verify that the Lepu SARS-CoV-2 Antigen Test Kit meets the regulatory requirements of your destination country. Check for local IVD registration, import permits, and any additional certifications needed for medical devices. Pharmonco Limited can provide the CE marking and BfArM approval documentation for your review.
Confirm the logistics for cold-chain compliance if required by your country’s regulations. Discuss Incoterms such as FOB Hong Kong or CIF to your port, and agree on payment terms like TT or LC. Lead times may vary based on order volume, so request a timeline for bulk shipments. Packaging options for retail or bulk export should also be clarified with the supplier.
Quality checks should include verifying the integrity of the test kits upon arrival, ensuring they are within the typical 18-month shelf life. Request a certificate of analysis or conformity to confirm compliance with EU standards. Inspection protocols may involve random sampling for sensitivity and specificity validation. Maintain documentation for traceability and regulatory audits.
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When sourcing Antigen Test (Germany Who Ce Approved) for your business, securing the right balance of quality and cost is essential. Pharmonco Limited, a verified supplier based in Hong Kong, offers this product with key specifications including CE IVD In-Vitro Diagnostic / BfArM Self-Test Approved Rapid Antigen Kit, Lateral Flow Immunochromatographic Assay (Colloidal Gold Label), and SARS-CoV-2 Nucleocapsid Protein (N Protein). By purchasing directly from the manufacturer or authorized exporter, buyers can negotiate favorable FOB prices starting at $2.8/Bags 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.
Importing Antigen Test (Germany Who requires careful attention to shipping logistics, customs compliance, and secure payment terms. Pharmonco Limited 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 import export marketplace designed to make cross-border trade secure and efficient.
Finding trustworthy partners is the foundation of successful importing. The supplier of this Antigen Test (Germany Who has been verified on our platform. 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 verified manufacturers and exporters across 200+ countries. Explore similar products in the Diagnostic Kits category and connect with top-tier exporters on our comprehensive online B2B marketplace. Start your sourcing journey today.
Importing Antigen Test (Germany Who 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).
The current listed wholesale price for Antigen Test (Germany Who Ce Approved) from Pharmonco Limited is $2.8/Bags on FOB terms from Hong Kong. Prices may vary depending on order volume, packaging, and destination. For the most accurate bulk quote, send a direct RFQ to Pharmonco Limited through EximNext.
The supplier, Pharmonco Limited, has set a Minimum Order Quantity (MOQ) of 1 Bags for Antigen Test (Germany Who. For sample requests or smaller trial orders, contact the supplier directly through our platform's inquiry system.
For international shipping and customs clearance, Antigen Test (Germany Who Ce Approved) is classified under HS Code 3822.00. Buyers should verify their local customs regulations to determine applicable import duties and taxes for this classification.
To import Antigen Test (Germany Who from Hong Kong, negotiate shipping terms (FOB, CIF, or EXW) directly with Pharmonco Limited. Ensure you have the necessary import licenses for Diagnostic Kits products in your destination country.
Yes, Pharmonco Limited is a verified supplier on EximNext. You can view their complete company profile, business registration details, certifications, and export history before placing a bulk order.
The key specifications for Antigen Test (Germany Who Ce Approved) supplied by Pharmonco Limited include CE IVD In-Vitro Diagnostic / BfArM Self-Test Approved Rapid Antigen Kit, Lateral Flow Immunochromatographic Assay (Colloidal Gold Label), and SARS-CoV-2 Nucleocapsid Protein (N Protein). For a complete technical data sheet or Certificate of Analysis (COA), send an inquiry directly to the supplier through EximNext.
Pharmonco Limited offers Antigen Test (Germany Who with standard export packaging. Custom packaging, private labeling, and OEM/ODM options may also be available for large wholesale orders.
Antigen Test (Germany Who is actively imported by buyers worldwide. Request a destination-specific CIF or CFR quote from Pharmonco Limited through our platform.
Pharmonco Limited maintains international quality certifications. These ensure that the Antigen Test (Germany Who meets international quality, safety, and regulatory standards required for cross-border trade.
Click "Request Quotation" on this product page, specify your required quantity, preferred shipping terms, and destination country. Pharmonco Limited will respond with a detailed wholesale quote including FOB pricing, lead time, and payment options.
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 Pharmonco Limited.
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