The kit is used to detect SARS-CoV-2, Influenza A, Influenza B, RSV and Adenovirus antigen in human nasal swab specimens.
 

Yes, BIOTEKE provides OEM customization services.

• Custom Brand Packaging: Private labeling with customer logo, layout, artwork, and outer box branding. 
• Multilingual IFUs: Instructions for Use (IFU) translated and formatted for specific regional market compliance.
• Flexible Kit Sizes: Configuration options for single-test packs, multi-test family/clinical boxes, or bulk economical packaging.
• Regulatory & Authorization Support: Provision of documentation, technical files, and certification assistance (e.g., EU IVDR CE) to support private-label market registration.

Yes, BIOTEKE's 5-in-1 Respiratory Antigen Test Kit is designed and manufactured to align with European regulatory requirements under EU 2017/746 (IVDR) and ISO 13485:2016 quality management standards.

Yes. BIOTEKE can support registration activities, but the scope of support depends on the target country and local regulatory requirements.

For B2B distributors/importers, BIOTEKE can typically provide regulatory documentation and technical support required for market access, including:

• Regulatory documents package
• CE/IVDR certification documentation (EU IVDR Regulation (EU) 2017/746)
• Declaration of Conformity
• Product technical file support documents
• Instructions for Use (IFU)
• Product specifications and labeling information
• Clinical performance documentation

• Registration support
• Guidance on local registration pathways
• Technical document preparation support
• Communication support between distributor/regulatory authority when required
• Additional documents requested by local authorities (depending on market)

BIOTEKE supports several collaboration models, depending on the partner’s business objectives, market strategy, and regulatory requirements.

The MOQ (Minimum Order Quantity) for the BIOTEKE 5-in-1 Respiratory Antigen Test Kit depends on the cooperation model, packaging format, and whether the order is for standard BIOTEKE products or customized/private label products.