Import Us Fda Eua Approved Covid Testing Kit From Korea — Buy in wholesale FOB from Supplier in South Korea (Republic Of Korea)
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US FDA EUA Approved Covid Testing Kit from Korea
The US FDA EUA Approved Covid Testing Kit from Korea supplied by SD Biosensor is a molecular diagnostic assay authorised for qualitative detection of SARS‑CoV‑2 nucleic acid in clinical specimens. The kit employs synthetic primers, probes, enzymes and buffer solutions on plastic 96‑well reaction plates, and the assay format is real‑time RT‑PCR. It is manufactured in South Korea and carries the US FDA Emergency Use Authorization, allowing export to markets that recognise this regulatory status.
Synthetic molecular reagents are standard components for RT‑PCR kits, providing high specificity and reproducibility. Typical kits of this class operate with a limit of detection around 100 copies per millilitre and complete a run in 1.5‑2 hours, which aligns with the performance of comparable FDA‑authorized tests. The plate format and reagent composition follow industry‑wide standards such as ISO 15189 for laboratory quality, although the supplier’s documentation should be reviewed for exact compliance details.
Primary customers include clinical laboratories, hospitals and public health agencies that require reliable high‑throughput testing for COVID‑19 screening. The kits are supplied in bulk pack sizes suitable for large‑scale testing programmes, and importers should verify the EUA certification and storage requirements before shipment. Payment and shipping conditions are negotiated directly with SD Biosensor, and buyers are advised to confirm Incoterms and any required cold‑chain logistics.
| Assay Type | Real‑Time RT‑PCR |
| Regulatory Status | US FDA Emergency Use Authorization (EUA) approved |
| Sample Type | Clinical specimens such as nasopharyngeal swabs |
| Detection Mode | Qualitative detection of SARS‑CoV‑2 nucleic acid |
| Reagent Composition | Synthetic primers, probes, enzymes and buffer solutions |
| Plate Format | Standard 96‑well plastic reaction plates |
| Limit of Detection | Typical 100 copies / mL |
| Run Time | Typical 1.5‑2 hours per batch |
| Storage Temperature | Typical -20 °C |
| Shelf Life | Typical 12 months when stored as specified |
SD Biosensor is based in South Korea (Republic Of Korea) and is listed under the harbour trust tier, indicating a verified presence on the platform despite a recorded response rate of 0 %. The company is one of the few manufacturers that has obtained US FDA Emergency Use Authorization for a COVID‑19 testing kit, and it reports having supplied 1.5 million testing units to the US government. Production capacity is stated to reach up to 600 000 units per day, ensuring the ability to meet large‑scale demand.
The supplier’s listing emphasizes the kit’s compliance with US regulatory standards and its suitability for high‑throughput laboratory workflows, but it does not provide specific details on minimum order quantities, lead‑time or pricing. Prospective buyers should request formal EUA documentation, a certificate of analysis for each batch and, if required, a validation report confirming assay performance under local laboratory conditions. All further negotiations are conducted directly with SD Biosensor.
The Standard M nCoV Real-Time Detection Kit by SD Biosensor is a US FDA EUA authorized molecular diagnostic assay for the qualitative detection of SARS-CoV-2 nucleic acid in clinical specimens. This real-time RT-PCR testing kit is manufactured in South Korea and is designed for use in clinical laboratories and healthcare settings performing COVID-19 screening. The kit supports high-throughput testing workflows and is distributed in bulk pack sizes suitable for importers and institutional buyers sourcing reliable diagnostic supplies.
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Sourcing US FDA EUA Approved Covid Testing Kit from Korea from SD Biosensor - South Korea (Republic Of Korea) Import Guide
Before placing an order, importers should obtain the US FDA EUA certificate and a detailed certificate of analysis for the specific kit batch. Confirm that the kit’s limit of detection, sample type compatibility and storage conditions meet the laboratory’s validation criteria. Request a material safety data sheet for the reagent components to ensure safe handling and disposal. Verifying these documents helps avoid regulatory or performance issues after the shipment arrives.
Logistics planning must address the cold‑chain requirement, as the reagents are stored at - 20 °C. Buyers should agree on an Incoterm such as CIF to a designated port and confirm that the carrier provides temperature‑controlled containers. Since the supplier’s response rate is listed as 0 %, establishing a direct contact channel is essential to obtain an accurate production lead time. Payment terms are typically negotiated on a TT or L/C basis; a pro‑forma invoice should detail these conditions along with any freight charges.
Upon receipt, a qualified laboratory should perform a verification run using the supplied positive and negative controls to confirm assay integrity. An inspection report that records reagent integrity, plate condition and temperature log during transport is advisable. Retaining the EUA letter, certificate of analysis and inspection documentation supports compliance with local health authority requirements and facilitates future audits or re‑validation processes.
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30 suppliersBuy Us Fda Eua Approved Covid in Bulk — Verified Supplier in South Korea (Republic Of Korea)
When sourcing Us Fda Eua Approved Covid Testing Kit From Korea for your business, securing the right balance of quality and cost is essential. SD Biosensor, a verified supplier based in South Korea (Republic Of Korea), offers this product with key specifications including Standard M nCoV Real-Time Detection Kit, SD Biosensor Inc., South Korea, and Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR). By purchasing directly from the manufacturer or authorized exporter, buyers can negotiate favorable FOB prices starting at $2030/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.
Us Fda Eua Approved Covid Specifications, Trade Terms & Pricing
Importing Us Fda Eua Approved Covid requires careful attention to shipping logistics, customs compliance, and secure payment terms. SD Biosensor 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.
About SD Biosensor — Supplier in South Korea (Republic Of Korea)
Finding trustworthy partners is the foundation of successful importing. The supplier of this Us Fda Eua Approved Covid 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.
Import Us Fda Eua Approved Covid — Shipping, Logistics & Customs
Importing Us Fda Eua Approved Covid 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 Us Fda Eua Approved Covid
What is the wholesale price of Us Fda Eua Approved Covid Testing Kit From Korea?
The current listed wholesale price for Us Fda Eua Approved Covid Testing Kit From Korea from SD Biosensor is $2030/Bags on FOB terms from South Korea (Republic Of Korea). Prices may vary depending on order volume, packaging, and destination. For the most accurate bulk quote, send a direct RFQ to SD Biosensor through EximNext.
What is the Minimum Order Quantity (MOQ) for Us Fda Eua Approved Covid?
The supplier, SD Biosensor, has set a Minimum Order Quantity (MOQ) of 1 Bags for Us Fda Eua Approved Covid. For sample requests or smaller trial orders, contact the supplier directly through our platform's inquiry system.
What is the HS Code for Us Fda Eua Approved Covid Testing Kit From Korea?
For international shipping and customs clearance, Us Fda Eua Approved Covid Testing Kit From Korea 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 Us Fda Eua Approved Covid from South Korea (Republic Of Korea)?
To import Us Fda Eua Approved Covid from South Korea (Republic Of Korea), negotiate shipping terms (FOB, CIF, or EXW) directly with SD Biosensor. Ensure you have the necessary import licenses for Diagnostic Kits products in your destination country.
Is SD Biosensor a verified supplier?
Yes, SD Biosensor 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.
What are the key specifications of Us Fda Eua Approved Covid Testing Kit From Korea?
The key specifications for Us Fda Eua Approved Covid Testing Kit From Korea supplied by SD Biosensor include Standard M nCoV Real-Time Detection Kit, SD Biosensor Inc., South Korea, and Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR). 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 Us Fda Eua Approved Covid?
SD Biosensor offers Us Fda Eua Approved Covid with standard export packaging. Custom packaging, private labeling, and OEM/ODM options may also be available for large wholesale orders.
Which countries import Us Fda Eua Approved Covid the most?
Us Fda Eua Approved Covid is actively imported by buyers worldwide. Request a destination-specific CIF or CFR quote from SD Biosensor through our platform.
What certifications does this Us Fda Eua Approved Covid supplier hold?
SD Biosensor maintains international quality certifications. These ensure that the Us Fda Eua Approved Covid meets international quality, safety, and regulatory standards required for cross-border trade.
How do I place a bulk order for Us Fda Eua Approved Covid Testing Kit From Korea on EximNext?
Click "Request Quotation" on this product page, specify your required quantity, preferred shipping terms, and destination country. SD Biosensor 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 SD Biosensor.
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