5-in-1 Respiratory Antigen Test Kit | IVD Partner

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EXPAND YOUR RESPIRATORY DIAGNOSTICS PORTFOLIO

FIVE PATHOGENS, ONE TESTING SOLUTION

1 Panel, 5 Answers

BIOTEKE 5-in-1 Respiratory Antigen Test Kit enables simultaneous detection of five respiratory pathogens using one sample and one test device.

SUBMIT

KEY PRODUCT ADVANTAGES

Multiplex Detection

Detect five respiratory pathogens in one test.

Simple Workflow

Anterior nasal swab collection with easy operation. One test, five clear answers.

Rapid Results

Results available within 15 minutes.

Flexible Applications

Available for multi-channel distribution and e-commerce.

Regulatory Support

CE self-testing certified under EU 2017/746(IVDR).

OEM Available

10+ EU languages packing & IFU available for multiple markets.

TESTING WORKFLOW

Preparation

Wash hands thoroughly, put the sample extraction tube into the kit box holder and peel off the aluminium foil seal.

Collect Sample

Take out the swab by holding the handle. Insert the swab into nostril and rub the swab against all of the inside for 5 circles. Then insert the swab into the sample extraction tube, stir and squeeze the tube for 5 times.

Perform Test

Screw the purple tube cap onto the tube and unscrew the top white cap. Take out the test card and put it on a flat, dry and clean surface. Squeeze 3 drops onto the sample well of the test card.

Read Result

Read the results within 15-20 minutes according to the user instruction. All used test components should be collected into the bio-safety bag.

TEST TYPE

Rapid Diagnostic Test
SAMPLE TYPE

Anterior nasal swab
DETECTION TARGET

SARS-CoV-2, Flu A, Flu B, RSV, ADV
TEST TIME

15-20 minutes
STORAGE

2~30 ℃
SHELF LIFE

24 months
PACKING

1T/2T/5T/20T/50T
REGULATORY STATUS

IVDR / CE

DESIGNED FOR GLOBAL HEALTHCARE MARKETS

Product Compliance

APPLICATIONS & MARKETS

Designed for Global Healthcare Distribution

Retail Pharmacy Networks

National pharmacy groups
Regional pharmacy chains
Independent pharmacies

Medical Device Distribution

Importers
National/Regional distributors
Diagnostic wholesalers

OEM & Private Label

Brand owners
Retail brands
Healthcare companies

Global Healthcare Markets

Quality manufacturing
Regulatory compliance
Stable supply

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Just fill out this quick form

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RESOURCE CENTER

2026-08-07

1.50MB

ICA2114-7 EU-TDA certificate(IVDR).PDF

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2026-04-15

2.27MB

ICA2114-7-2026-01-26-A1 Benutzerhandbuch (Deutsch)

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2026-04-15

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ICA2114-7-2026-01-16-A1 -Instrukcja obsługi (po polsku)

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ICA2114-7-2026-01-26-A1 Kullanım Kılavuzu (Turkce)

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ICA2114-7-2026-01-16-A1 User Manual(English)

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ICA2114-7-2026-01-26-A1 Korisnički priručnik (hrvatski)

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ICA2114-7-2026-01-26-A1 Použivateľska priručka (slovenčina)

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ICA2114-7-2025-09-19-A1 Manual de usuario (espanol)

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ICA2114-7-2026-01-26-A1 (suomi+Svenska)

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ICA2114-7-2026-01-26-A2 User Manual(Greek)

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2026-04-15

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ICA2114-7-2026-01-26-A1 Manuale utente (italiano)

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2026-04-15

5.73MB

ICA2114-7-2026-01-26-A1 Manual de utilizare (in limba romana)

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2026-04-15

4.68MB

ICA2114-7-2026-01-26-A1 Manuel dutilisation (francais)

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2026-08-07

1.50MB

ICA2114-7 EU-TDA certificate(IVDR).PDF

Download

2026-04-15

2.27MB

ICA2114-7-2026-01-26-A1 Benutzerhandbuch (Deutsch)

Download

2026-04-15

3.15MB

ICA2114-7-2026-01-16-A1 -Instrukcja obsługi (po polsku)

Download

2026-04-15

3.03MB

ICA2114-7-2026-01-26-A1 Kullanım Kılavuzu (Turkce)

Download

2026-04-15

3.29MB

ICA2114-7-2026-01-16-A1 User Manual(English)

Download

2026-04-15

3.00MB

ICA2114-7-2026-01-26-A1 Korisnički priručnik (hrvatski)

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2026-04-15

3.13MB

ICA2114-7-2026-01-26-A1 Použivateľska priručka (slovenčina)

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2026-04-15

4.47MB

ICA2114-7-2025-09-19-A1 Manual de usuario (espanol)

Download

2026-04-15

3.38MB

ICA2114-7-2026-01-26-A1 (suomi+Svenska)

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2026-04-15

2.97MB

ICA2114-7-2026-01-26-A2 User Manual(Greek)

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2026-04-15

3.95MB

ICA2114-7-2026-01-26-A1 Manuale utente (italiano)

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2026-04-15

5.73MB

ICA2114-7-2026-01-26-A1 Manual de utilizare (in limba romana)

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2026-04-15

4.68MB

ICA2114-7-2026-01-26-A1 Manuel dutilisation (francais)

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FAQ

What pathogens does BIOTEKE 5-in-1 Respiratory Antigen Test Kit detect?

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

Can BIOTEKE provide OEM packaging?
Yes, BIOTEKE provides OEM customization services.

Available OEM Packaging 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.

Is the product IVDR compliant?

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.

Can BIOTEKE support registration?
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)

What collaboration methods does BIOTEKE support?

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

1. Authorized Distribution Partnership
For IVD distributors, importers, pharmacy chains, and healthcare suppliers.

2. Private Label / OEM Partnership
For companies that want to launch their own pregnancy test brand.

What is the MOQ?

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.

EXPLORE RESPIRATORY DIAGNOSTICS PARTNERSHIP OPPORTUNITIES

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zr@bioteke.cn

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