Custom Kit Solutions for Point-of-Care Diagnostics Providers
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1. Introduction: The Role of Custom Kit Solutions in Point-of-Care Diagnostics
Point-of-care (POC) diagnostics have revolutionized the healthcare industry by bringing rapid testing capabilities closer to patients. From clinics and emergency rooms to pharmacies and home settings, the need for quick, accurate, and easy-to-use diagnostic kits has never been higher.
But as the demand for POC testing grows, so does the need for customization. Healthcare providers, diagnostic device companies, and distributors are increasingly turning to custom kit solutions to meet specific clinical, regional, and regulatory requirements. Custom POC diagnostic kits provide a tailored approach to sample collection, test compatibility, storage, and user instructions—delivering not only precision in diagnostics but also operational efficiency.
Why Custom Kit Solutions Are Essential in POC Testing
- Targeted Clinical Use: Kits can be designed for specific diseases or patient demographics.
- Ease of Use: Components can be simplified for use by non-laboratory personnel.
- 規制遵守: Kits can be customized to meet regional compliance (e.g., FDA, CE).
- 業務効率: Reduces errors by bundling all necessary components.
- Branding & Private Labeling: Companies can white-label kits under their own brand.
Industries Benefiting from Custom POC Kits
| 業界セクター | ユースケース | キットコンポーネント |
|---|---|---|
| 病院と診療所 | Respiratory infections, cardiac markers | Swabs, test cassettes, buffer tubes |
| Mobile Clinics | COVID-19, HIV, Malaria | Compact packaging, rapid test strips |
| Pharmacies | Self-testing for glucose, pregnancy | Instructions, lancets, test strips |
| Research Labs | Clinical trials, pilot studies | Custom sample collection tools |
| OEM/IVD Companies | Device bundling | Device + collection + packaging |
For B2B buyers—including hospitals, diagnostic service providers, and distributors—custom kit solutions offer a streamlined way to procure diagnostics tailored to their workflow and patient needs. This blog explores how to source, customize, and benefit from wholesale point-of-care diagnostic kits—especially from top-tier suppliers like Jiangsu Hanheng, a global leader in medical testing consumables.
2. Market Trends: Growth of Point-of-Care Testing & Customization Demand
The market for point-of-care diagnostics is experiencing exponential growth, driven by the increasing need for rapid testing and decentralized healthcare delivery. Customization has emerged as a key differentiator in this market, especially for companies aiming to offer specialized or branded diagnostic solutions.
世界市場概要
| パラメータ | 値 |
|---|---|
| Global POC Diagnostics Market Size (2023) | $38 Billion |
| Expected CAGR (2024–2030) | 9.5% |
| Major Regions | 北米、ヨーロッパ、アジア太平洋地域 |
| 主要ドライバー | Infectious diseases, chronic illnesses, aging population |
Top Factors Driving Custom Kit Demand
- COVID-19 & Respiratory Illnesses: Surge in demand for rapid, easy-to-use kits.
- Chronic Disease Management: Diabetes, cardiovascular health require routine testing.
- Remote Healthcare Growth: Telehealth and home diagnostics are booming.
- Regulatory Variability: Different countries require different labeling, packaging, and components.
- ブランド差別化: OEMs and distributors want kits in their own branding.
B2B Buyer Preferences for Custom Kits
| バイヤーの種類 | カスタマイズのニーズ |
|---|---|
| 販売業者 | White-label branding, multi-language manuals |
| 子宮頸部および泌尿生殖器検体の採取 | Kits tailored to clinical protocols |
| OEM Diagnostic Companies | Bundled collection + testing tools |
| Eコマース販売者 | User-friendly packaging, self-test compatibility |
| NGOs & Governments | Bulk procurement, disease-specific kits |
The trend toward customized kits is also being bolstered by technological innovation in materials, packaging, and manufacturing—an area where advanced suppliers like Jiangsu Hanheng excel.
3. Key Components to Include in Custom Diagnostic Kits
When developing or sourcing a custom diagnostic kit, it’s essential to consider the components that align with the intended use case. A well-designed kit ensures sample integrity, reduces user error, and supports seamless test processing.
Common Components in Point-of-Care Diagnostic Kits
| コンポーネント | 機能 | カスタマイズ・オプション |
|---|---|---|
| Sampling Device | Collects the specimen (nasal, oral, cervical, etc.) | Swab size, material, sterility |
| Transport Medium | Preserves sample during transit | Type (VTM, UTM, dry), volume |
| Test Cartridge/Strip | Conducts diagnostic test | Compatibility with analyzers |
| Buffer Solution | Aids in sample processing | Vial design, cap type |
| Instruction Manual | Guides user in test procedure | Language, QR code for video |
| パッケージング | Holds all components securely | Branding, tamper-proof seals |
Specialized Kits Offered by Jiangsu Hanheng
As a leading manufacturer of medical testing consumables, Jiangsu Hanheng offers a wide range of components that can be integrated into customized kit solutions:
- 綿棒: Nasal, throat, cervical; available in flocked, foam, or cotton tip formats.
- 子宮頸部サンプルコレクター: Sterile and ergonomically designed for gynecological exams.
- Sample Collection Boxes: Designed for safe transport and storage of biological samples.
- Gynecological Scrapers & Brushes: For Pap smear and cancer screenings.
- 滅菌包装: Custom labeling and cleanroom-assembled for safety.
Considerations for B2B Wholesale Orders
- 最小注文数量（MOQ）: Vary based on component type and customization.
- 100,000ユニット以上の平均ターンアラウンド時間はどれくらいですか？: Typically 2–6 weeks depending on complexity.
- 規制認証: ISO13485, CE, FDA—essential for market entry.
- プライベートラベリング: Most suppliers, including Hanheng, offer OEM/ODM services.
By selecting the right mix of components and aligning them with clinical goals and regulatory requirements, healthcare companies and distributors can deliver high-performing, market-ready diagnostic kits.
4. Top Global Suppliers for Custom Point-of-Care Diagnostic Kits
As the demand for customizable point-of-care (POC) diagnostic kits surges, a handful of global suppliers have established themselves as trusted partners for healthcare providers, diagnostic brands, and wholesale distributors. These companies offer comprehensive kit-building capabilities, regulatory expertise, and scalable production—all crucial for B2B procurement.
Leading Global Suppliers
Below is a comparison table of top-tier suppliers offering custom point-of-care diagnostic kit solutions:
| 会社名 | 国名 | Core Strengths | 認証 | Customization Services |
|---|---|---|---|---|
| 江蘇漢恒医療技術有限公司 | 中国 | Full-range medical testing consumables, OEM/ODM, cleanroom production | ISO9001、ISO13485、CE、FDA | Full-kit assembly, private labeling, packaging |
| BD（ベクトン・ディッキンソン・アンド・カンパニー） | アメリカ | Diagnostic devices, sampling technologies | ISO13485、FDA、CE | OEM test components |
| サーモフィッシャーサイエンティフィック | アメリカ | Molecular diagnostics, sample collection | FDA、CE、ISO | Kit bundling with molecular platforms |
| Bio-Rad Laboratories | フランス | Immunoassay testing kits, OEM services | ISO、CE | Private labeling, clinical test bundling |
| Qiagen | ドイツ | Molecular testing, sample prep | CE、ISO 13485 | End-to-end diagnostic solutions |
Why Jiangsu Hanheng Is the Top Choice in China
中国のサプライヤーの中で、 江蘇漢恒医療技術有限公司 stands out due to its:
- World-class manufacturing facilities, including a 10,000㎡ Class 100,000 cleanroom.
- Extensive product line for respiratory, urological, and gynecological testing.
- Custom packaging and white-labeling capabilities for global distributors.
- ISO9001, ISO13485, CE, and FDA certified—ensuring compliance with major markets.
- Efficient global delivery and logistics support for wholesale buyers.
Whether you are an IVD brand looking to bundle test kits, or a distributor targeting hospitals and clinics, partnering with a reliable and certified supplier like Hanheng ensures product quality, scalability, and market readiness.
5. Why More Healthcare Distributors Are Sourcing Custom Kits from Asia
Asia, particularly China, has evolved into a global hub for the production and customization of medical diagnostic kits. Distributors, importers, and healthcare procurement managers are increasingly sourcing diagnostic kits from Asian suppliers, driven by price advantage, manufacturing capacity, and customization flexibility.
Key Advantages of Sourcing Custom Kits from Asia
| 利点 | 説明 |
|---|---|
| コスト効率 | Lower production and labor costs without compromising quality. |
| High Production Volume | Ability to fulfill large-scale wholesale orders quickly. |
| 高度な製造 | Cleanroom facilities and automation ensure product consistency. |
| OEM/ODMの柔軟性 | Private labeling, custom packaging, and tailored kit configurations. |
| Regulatory Awareness | Many Asian manufacturers are certified for global markets (FDA, CE, ISO). |
Preferred Kit Components Sourced from Asia
- – 臨床および微生物学的用途に最適: Widely used for respiratory and gynecological sampling.
- Sampling Tubes & VTM: High-precision production with automated filling.
- Sterile Brushes & Scrapers: For cervical and gynecological diagnostics.
- 包装ソリューション: Custom boxes, sealed pouches, multi-language labels.
Case Study: Why Distributors Choose Hanheng
Jiangsu Hanheng is a prime example of why Asia, and China in particular, is the go-to region for custom medical kits:
- グローバルリーチ: Serves clients across North America, Europe, and Southeast Asia.
- フルカスタマイズ: Offers component selection, printing, and packaging tailored to client needs.
- 研究開発能力: Continuously innovates to support next-gen diagnostics.
- Compliance Ready: All products meet international regulatory standards.
For wholesale distributors looking to expand their diagnostic product lines with minimal lead time and maximum customization, Asia—especially China—offers unmatched value.
6. Why Choose Jiangsu Hanheng for Custom Medical Testing Kits
江蘇漢恒医療技術有限公司 is not just a manufacturer—it is your strategic partner in delivering world-class custom diagnostic kits tailored for point-of-care testing. Whether you’re a multinational distributor, hospital network, or a diagnostic device company, Hanheng provides end-to-end solutions that ensure accuracy, reliability, and brand consistency.
ハンヘンの特徴は？
| 特徴 | ベネフィット |
|---|---|
| 高度な製造 | 10,000㎡ Class 100,000 cleanroom ensures sterile and compliant production. |
| 鼻腔および咽頭スワブ（フロッキングおよびフォーム） | From nasal swabs to gynecological kits, all components are developed in-house. |
| カスタムキットアセンブリ | Clients can specify each item, packaging type, labeling, and branding. |
| グローバル認証 | ISO9001, ISO13485, CE, FDA, utility model patents. |
| 研究開発イノベーション | Dedicated team continuously develops and optimizes kit components. |
Product Range for Custom Kits
Hanheng’s products are ideal for building custom kits for various clinical and diagnostic applications:
- 綿棒: Nasal, throat, cervical – flocked, polyester, or foam-tipped.
- 使い捨て子宮頸部サンプルコレクター: Intuitive design for user comfort.
- 無菌子宮頸部採取ブラシ: Precision sampling for cytology.
- 婦人科用スクレーパーとキット: Supports Pap smear and HPV testing.
- Sampling Boxes & Tubes: Leak-proof, sterile, and customizable.
- 婦人科検査キット: All-in-one setups for OB/GYN clinics.
OEM/ODMサービス
Hanheng offers full-spectrum customization services:
- ブランディングとロゴ印刷
- Multilingual instruction manuals
- カスタムパッケージデザイン
- 規制文書のサポート
- Low MOQs for growing businesses
Partner With Confidence
Jiangsu Hanheng is trusted by hospitals, laboratories, NGOs, and diagnostic brands globally. Their commitment to innovation, quality, and customization makes them the preferred supplier for businesses that demand excellence in POC diagnostic kits.
If you’re looking for a reliable wholesale partner to deliver private label or custom branded diagnostic kits, 江蘇漢恒 is your trusted solution provider.
検診プログラム向けの最高の医療HPVブラシサプライヤー— Hanheng Medical www.hanheng-medical.com
📧 Eメール： [email protected]
7. How to Customize and Order Point-of-Care Kits for Wholesale Supply
For wholesale buyers, distributors, and healthcare procurement managers, sourcing a custom point-of-care (POC) diagnostic kit involves more than selecting products off the shelf. It requires thoughtful planning, regulatory considerations, and a trusted manufacturing partner who can deliver on quality, scalability, and customization. 江蘇漢恒医療技術有限公司 provides a streamlined process that enables clients to design, order, and receive high-quality diagnostic kits tailored to their market’s unique needs.
Step-by-Step Guide to Ordering Custom Diagnostic Kits from Hanheng
| ステップ | 説明 | Tips for B2B Buyers |
|---|---|---|
| 1. 要件を定義する | Determine clinical application, sample type, and test environment. | Consider end-user skill level (lab techs vs. patients). |
| 2. Select Components | Choose swabs, sample tubes, buffers, collection tools, and packaging. | Use Hanheng’s catalog to evaluate available options. |
| 3. Customize Packaging | Brand design, language preferences, and labeling formats. | Hanheng supports full OEM/private labeling. |
| 4. Confirm Regulatory Needs | Identify certifications needed for your target region (FDA, CE, etc.). | Hanheng offers products compliant with ISO9001, ISO13485, CE, and FDA. |
| 5. Request Sample Kits | Test product quality and compatibility. | Evaluate usability, packaging integrity, and user instructions. |
| 6. Finalize Order & Pricing | Confirm MOQs, unit costs, and lead times. | Bulk discounts available for large orders. |
| 7. Manufacturing & QA | Kits are assembled in cleanroom environments and undergo quality checks. | Hanheng’s Class 100,000 cleanroom ensures sterility and precision. |
| 8. Shipping & Documentation | Receive kits with full documentation for customs and compliance. | Hanheng supports international logistics and documentation. |
Customization Options Available from Hanheng
Hanheng offers extensive customization capabilities tailored to B2B needs:
- Swab Types: Flocked, polyester, or foam tips with different shaft materials.
- Sampling Tools: Cervical brushes, gynecological scrapers, and collectors.
- パッケージング: Individual foil pouches, rigid boxes, tamper-evident seals.
- Instruction Manuals: Multilingual, diagrammatic, or QR code-based guides.
- ブランディング: Custom logo, color schemes, and private label packaging.
- ドキュメンテーション: Includes Certificates of Analysis (CoA), MSDS, CE/FDA/ISO certifications.
Minimum Order Quantities & Lead Times
| 製品タイプ | MOQ | リードタイム |
|---|---|---|
| Standard Swab Kits | 5,000台 | 2～4週間 |
| Custom Gynecological Kits | 3,000 units | 3～5週間 |
| Full Diagnostic Kits (with branding) | 10,000台 | 4～6週間 |
Hanheng is flexible with growing businesses and can accommodate smaller MOQs for pilot projects or market testing. Fast-track production is also available for urgent medical needs.
📧 連絡先： [email protected]
🌐 ウェブサイト： www.hanheng-medical.com
8. FAQs: Common Questions About Custom Point-of-Care Diagnostic Kits
Q1: What is included in a custom diagnostic kit?
カスタムキットには通常、以下のものが含まれる：
- Sample collection device (e.g., nasal swab, cervical brush)
- Sample transport medium (e.g., VTM or dry tube)
- Test cartridges or strips (if applicable)
- Buffer solutions or reagents
- Instruction manual (multi-language support available)
- Custom packaging (pouches, boxes with branding)
Q2: Can I order kits with my company branding?
Yes. Jiangsu Hanheng specializes in OEM and private label manufacturing. You can customize:
- Logo and color scheme
- Packaging design (boxes, pouches)
- Instruction materials
- カスタムボックスサイズと材料（環境に優しく、リサイクル可能）
Q3: What certifications do Hanheng’s products hold?
Hanheng’s products are certified with:
- ISO9001 – Quality Management Systems
- ISO13485 – Medical Device Quality Systems
- CE – European Conformity
- FDA – U.S. Food and Drug Administration
- Utility Model Patents for innovative designs
These certifications ensure that products meet global regulatory requirements.
Q4：注文を受け取るまでにどのくらい時間がかかりますか？
Production lead times typically range from 2 to 6 weeks depending on:
- Product complexity
- Order quantity
- Customization level
Shipping times vary based on destination country and shipping method (air vs. sea).
Q5: Does Hanheng provide regulatory documents?
Yes, all shipments include:
- Certificate of Analysis (CoA)
- 製品安全データシート（MSDS）
- Declarations of conformity (CE/FDA)
- Custom clearance documentation
Hanheng’s regulatory team also assists with product registration in your market.
Q6：最小注文数量（MOQ）は？
It depends on the product:
- Swabs and sample tubes: 5,000 units
- Custom diagnostic kits with branding: 10,000 units
- Specialty kits (e.g., gynecological): 3,000 units
Smaller MOQs may be possible for pilot runs or initial market testing.
Q7: Can you help with kit design?
Absolutely. Hanheng offers consultative support to help you:
- Choose the right components
- Design user-friendly packaging
- Ensure regulatory compliance
- Optimize for your target market
Their experienced R&D and product design teams work closely with clients to develop kits that are both functional and market-ready.
9. Conclusion & Call-to-Action
Point-of-care diagnostics are transforming the way healthcare services are delivered, making fast and accurate testing accessible in clinics, remote settings, and even homes. As the industry moves toward decentralization and patient-centric care, the demand for customized diagnostic kits is at an all-time high.
For healthcare providers, diagnostic brands, and medical distributors, custom kit solutions offer a strategic advantage—allowing you to tailor your offerings to specific clinical needs, regional regulations, and brand identities. By partnering with a reliable and globally certified manufacturer like Jiangsu Hanheng, you ensure that your diagnostic kits meet the highest standards of quality, compliance, and usability.
無菌性（ガンマ滅菌、EO滅菌、非滅菌）
- 🏭 Advanced Manufacturing: Cleanroom precision and scalable production.
- 🌎 Global Certifications: ISO9001, ISO13485, CE, FDA.
- 📦 OEM/ODM Services: Full branding, packaging, and documentation support.
- 💡 Innovation-Driven: Strong R&D team for continuous product development.
- 🔄 End-to-End Solution: From component selection to shipping logistics.
Whether you’re a distributor expanding your product line or a healthcare provider sourcing kits for clinical use, Jiangsu Hanheng offers the reliability, customization, and performance you need to succeed in the point-of-care diagnostics space.
👉 Learn more or request a quote:
🌐 訪問： www.hanheng-medical.com
📧 連絡先： [email protected]
Let Hanheng help you deliver diagnostic solutions that make a real difference.
江蘇漢恒医療技術有限公司
当社は、精密性、安全性、グローバルコンプライアンスを追求する、高品質な医療用消耗品のトップメーカーです。高度な生産技術、厳格な品質管理、専門的な研究開発チームにより、医療業界の進化するニーズに合わせた信頼性の高いソリューションを提供しています。
