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The Tutmonda COVID-19 Antigen Test Stripe is a lateral flow immunoassay designed for rapid detection of SARS-CoV-2 nucleocapsid proteins in human blood or serum samples. Results are available within 15 to 20 minutes, with a claimed sensitivity of 91.27% (95% CI: 84.92% - 95.56%) and specificity of 100% (95% CI: 99.22% - 100%). The test strip uses a nitrocellulose membrane with colloidal gold-conjugated antibodies and SARS-CoV-2 specific antigens to produce visible lines indicating positive or negative results.
The device is CE-marked and listed by the German Federal Institute for Drugs and Medical Devices (BfArM), confirming its compliance with EU IVDR for in vitro diagnostic use. It is manufactured under controlled conditions suitable for clinical and point-of-care environments. The membrane composition and conjugate chemistry align with standard rapid antigen test designs used in European diagnostic markets, though no external validation data beyond the provided confidence intervals is available from the supplier.
This product is sourced primarily by medical distributors, hospital procurement departments, and public health agencies in regions requiring scalable point-of-care screening. Bulk packaging is available in sealed foil pouches, typically 25 or 50 tests per box, with outer cartons holding 100 to 500 units. Trade terms require confirmation of Incoterms, lead time, and storage conditions, as the test strips must be kept between 2°C and 30°C and used within 12 months of manufacture.
| Test format | Lateral flow immunoassay |
| Sample type | Human blood or serum |
| Detection target | SARS-CoV-2 nucleocapsid protein |
| Result time | 15 to 20 minutes |
| Sensitivity | 91.27% (95% CI: 84.92% - 95.56%) |
| Specificity | 100% (95% CI: 99.22% - 100%) |
| Membrane material | Nitrocellulose with colloidal gold-conjugated antibodies |
| Packaging | Individual foil pouches; bulk options available in cartons of 100 to 500 units |
| Storage temperature | 2°C to 30°C, typical for rapid antigen devices |
| Shelf life | 12 months from manufacture, standard for CE-marked IVDs |
Tutmonda is a supplier registered in Germany with a verified harbor trust tier and no public record of manufacturing facilities or clinical validation partnerships. The listing confirms BfArM registration for the antigen test stripe but provides no details on company history, staff size, export volume, or prior client engagements. All claims are limited to product performance data and regulatory status.
No financial data, workforce figures, or production capacity are disclosed. The supplier does not appear to hold ISO 13485 certification or publish quality manuals. Buyers should request independent batch-level test reports and verify BfArM listing validity before placing orders. The absence of response rate data suggests limited buyer communication infrastructure.
This SARS-CoV-2 antigen speed test strip delivers rapid, accurate COVID-19 detection from human blood or serum samples within 15 to 20 minutes, making it ideal for point-of-care and clinical screening environments. CE-marked and designed for in vitro diagnostic use, it is suitable for import/export distributors and healthcare procurement buyers sourcing at scale. Bulk packaging options available for large-volume medical supply chains.
| 企业类型 | Supplier |
| 成立年份 | Contact Supplier |
| Employees | Contact Supplier |
| Annual Revenue | Contact Supplier |
| Main Products | View Products Tab |
| Major Markets | Global |
| 响应时间 | <4h |
| 响应率 | Contact Supplier |
Before ordering, verify the BfArM listing number for the exact product batch and confirm it matches the supplier’s documentation. Request a copy of the CE Declaration of Conformity and ensure the product is listed under IVDR 2017/746. Confirm that the test strip is not a rebranded or repackaged product from another manufacturer, as this is common in the diagnostic supply chain.
Lead time for bulk orders is not stated; buyers must confirm production cycles and shipping methods. Incoterms should be negotiated as FOB Hamburg or DAP destination, with proof of temperature-controlled transport. Payment terms are typically 30% advance, 70% against shipping documents, but must be agreed in writing with the supplier.
Quality checks should include random batch testing for sensitivity and specificity using certified reference samples. Inspect packaging for seal integrity and expiration dates. Require a Certificate of Analysis per batch showing lot number, storage conditions, and test results. Retain samples for third-party lab verification if used in clinical settings.
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When sourcing Covid-19 Antigen Test Stripe for your business, securing the right balance of quality and cost is essential. Tutmonda, a verified supplier based in Germany, offers this product with key specifications including CE-Marked In Vitro Diagnostic (IVD) / Point of Care Testing (POCT), Lateral Flow Immunoassay (Colloidal Gold), and Human whole blood, serum, or plasma. By purchasing directly from the manufacturer or authorized exporter, buyers can negotiate favorable FOB prices starting at $1.504.00./Unit and manage bulk orders with a minimum order quantity (MOQ) of 1 Unit. This product is actively traded under HS Code 3822.00, making it a staple in the COVID-19 Detection Kit sector with strong demand from importing countries worldwide.
Importing Covid-19 Antigen Test Str requires careful attention to shipping logistics, customs compliance, and secure payment terms. Tutmonda 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 Covid-19 Antigen Test Str 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 COVID-19 Detection Kit category and connect with top-tier exporters on our comprehensive online B2B marketplace. Start your sourcing journey today.
Importing Covid-19 Antigen Test Str 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 Covid-19 Antigen Test Stripe from Tutmonda is $1.504.00./Unit on FOB terms from Germany. Prices may vary depending on order volume, packaging, and destination. For the most accurate bulk quote, send a direct RFQ to Tutmonda through EximNext.
The supplier, Tutmonda, has set a Minimum Order Quantity (MOQ) of 1 Unit for Covid-19 Antigen Test Str. For sample requests or smaller trial orders, contact the supplier directly through our platform's inquiry system.
For international shipping and customs clearance, Covid-19 Antigen Test Stripe 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 Covid-19 Antigen Test Str from Germany, negotiate shipping terms (FOB, CIF, or EXW) directly with Tutmonda. Ensure you have the necessary import licenses for COVID-19 Detection Kit products in your destination country.
Yes, Tutmonda 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 Covid-19 Antigen Test Stripe supplied by Tutmonda include CE-Marked In Vitro Diagnostic (IVD) / Point of Care Testing (POCT), Lateral Flow Immunoassay (Colloidal Gold), and Human whole blood, serum, or plasma. For a complete technical data sheet or Certificate of Analysis (COA), send an inquiry directly to the supplier through EximNext.
Tutmonda offers Covid-19 Antigen Test Str with standard export packaging. Custom packaging, private labeling, and OEM/ODM options may also be available for large wholesale orders.
Covid-19 Antigen Test Str is actively imported by buyers worldwide. Request a destination-specific CIF or CFR quote from Tutmonda through our platform.
Tutmonda maintains international quality certifications. These ensure that the Covid-19 Antigen Test Str 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. Tutmonda 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 Tutmonda.
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