Disposable Virus Sampling Swab Kit

CE & FDA 510(k) Certified | OEM & Private Label Available

BIOTEKE Disposable Virus Sampling Kit is designed for safe, reliable, and efficient collection, preservation, and transport of viral specimens. Each kit consists of a pre‑filled viral transport medium (VTM) tube and a sterile disposable swab, ensuring sample integrity for downstream molecular diagnostics such as RT‑PCR and antigen testing.

Manufactured under a strict quality management system, this product is CE certified for the EU market and FDA 510(k) cleared for the US market, making it suitable for global distribution through professional B2B channels.

Product Overview

The Disposable Virus Sampling Kit is widely used for collecting respiratory and other viral samples from patients in clinical and laboratory settings. The optimized viral preservation solution effectively stabilizes viral nucleic acids and antigens during storage and transportation, reducing the risk of sample degradation.

This product is ideal for:

• Medical laboratories

• Hospitals and clinics

• Diagnostic kit manufacturers

• Medical device distributors and importers

• Public health and research institutions

Key Features & Benefits

• Complete Sampling Solution: VTM tube pre‑filled with virus preservation solution + sterile disposable swab

• Sample Integrity Guaranteed: Maintains viral RNA/DNA stability for accurate diagnostic results

• CE Certified & FDA 510(k) Cleared: Meets EU and US regulatory requirements

• OEM & Private Label Support: Custom labeling, packaging, and instructions available

• Bulk Supply for B2B Buyers: Stable production capacity and competitive wholesale pricing

• Sterile & Safe: Individually packed components, EO or gamma sterilized

• Compatible with PCR & Antigen Tests: Suitable for molecular and immunoassay workflows

Technical Specifications

• Tube Volume: 2ml / 3ml (customizable)

• Transport Medium: Viral Transport Medium (VTM)

• Swab Type: Nylon flocked swab

• Sterilization Method: EO / Gamma

• Shelf Life: 24 months

• Storage Conditions: 2–30°C

• Packaging: Individual kit or bulk packaging available

Regulatory Compliance

• EU: CE Marked (In Vitro Diagnostic accessory)

• USA: FDA 510(k) Cleared

• Quality System: ISO 13485 certified manufacturing

Full regulatory documentation, including IFU, Declaration of Conformity, and FDA clearance details, is available upon request for qualified B2B customers.

OEM & Private Label Services

We offer flexible OEM and private label solutions tailored to your market needs:

• Custom tube labels and carton design

• Multilingual IFU customization

• Logo printing and brand integration

• Packaging format optimization

• Support for product registration in local markets

Applications

• Respiratory virus sampling

• Infectious disease diagnostics

• PCR and molecular testing workflows

• Antigen rapid test sample collection

• Clinical research and surveillance programs

Why Choose Us

• Experienced IVD manufacturer and global supplier

• Stable quality and batch‑to‑batch consistency

• Fast production lead time for bulk orders

• Professional support for distributors and importers

• Long‑term OEM and strategic partnership capability

Ordering & Inquiry

This product is supplied exclusively through B2B channels.

Contact us today to request:

• Wholesale pricing

• OEM / private label quotation

• Samples for evaluation

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Download

VTM brochure.pdf