Discover the latest in separator gel blood collection tube technology, including technical parameters, manufacturing process, industry applications, authoritative standards, and product comparison. This comprehensive resource is crafted for healthcare, laboratory, and medical device professionals searching for high-performance separator tubes and optimal serum separator tube price solutions.
Industry Trends of Separator Gel Blood Collection Tubes
The global separator gel blood collection tube market has grown steadily over the last decade, with compound annual growth rates (CAGR) between 5.1% and 7.3% according to international laboratory supply analyses (2021–2024). Major drivers include the advancement of minimally invasive diagnostic techniques, increased demand for rapid sample processing in hospitals, and the global growth of clinical research. According to the Markets and Markets Report 2023, the Asia-Pacific region leads the growth due to expanding healthcare infrastructures and laboratory modernization.
- Widespread adoption in clinical chemistry, immunology, virology, and transfusion medicine
- Rising need for EDTA plasma separator tubes in molecular diagnostics and oncology
- Increasing healthcare regulations (ISO 15189, FDA 21 CFR Part 820) mandating high traceability and performance
- Market preference for serum separator tubes with optimized gel density and advanced plastic polymers
Typical industry use cases involve high-throughput laboratories, emergency care, blood banking, and pharmaceutical R&D settings.
High-transparency separator tube with advanced gel formulation—ideal for modern clinical labs.
Technical Parameters: Separator Gel Blood Collection Tubes
Parameter |
Separator Tube |
EDTA Plasma Separator Tube |
Gel Separator-EDTAK2 Tube |
Serum Separator Tube |
Tube Material |
Polyethylene Terephthalate (PET) |
PET |
Borosilicate Glass / PET |
PET |
Gel Type |
Inert polymer gel |
Silica-based gel + EDTA K2 |
Advanced polyether polymer |
Silicone-based |
Volume |
2ml-10ml |
2ml-8ml |
3ml/5ml/7ml |
3ml/5ml/7ml/10ml |
Closure Type |
Butyl rubber |
Butyl rubber |
Synthetic butyl |
Butyl/silicone |
Anticoagulant |
None |
EDTA K2, EDTA K3 |
EDTA K2 + Gel |
None |
ISO Certification |
ISO 13485 |
ISO 15189 & ISO 13485 |
ISO 15189, FDA Registered |
ISO 13485 |
Centrifugation Speed |
1300–2000g |
1300–2500g |
1500–2200g |
1300–2000g |
Serum/Plasma Yield |
>90% |
>95% |
>96% |
>90% |
Usable Life |
18 months |
18 months |
24 months |
12-18 months |
Common Applications |
Clinical biochemistry |
Genomics, Hematology |
Diagnostics, Genetics, Research |
Serum chemistry, Immunology |
Serum Separator Tube Price (per 1000 units) |
$38–52 |
$54–68 |
$62–78 |
$36–48 |
Note: All listed separator tubes conform to ISO 13485 and are produced in controlled-class facilities per FDA 21 CFR Part 820. Technical parameters verified via major global suppliers and laboratory device audits (2023).
Manufacturing Process of Separator Gel Blood Collection Tubes
1
Raw Material Selection: High-purity PET resin and medical-grade additives selected; gel compounds sourced from ISO 9001-approved partners.
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2
Tube Formation: Injection molding crafts each tube to uniform wall thickness (0.75-1mm), ensuring identical sample performance.
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3
Gel Injection: Automated CNC dosing injects a precise separator gel column. Viscosity is calibrated to 0.95±0.03 Pa·s for optimal separation.
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4
Additive Integration: (If applicable) EDTA, clot activator, or other anticoagulant agents are dosed for specialty tubes, using 6-sigma dosing controls.
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5
Stopper & Closure: Synthetic butyl or medical-grade silicone stoppers installed, oxygen-impermeable to maintain sample integrity.
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6
Sterilization: Gamma irradiation or E-beam sterilization to <10-6 CFU sterility assurance, validated to ISO 11137 & ANSI/AAMI ST72.
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7
Quality Inspection: Multi-parameter testing—seal integrity, vacuum, gel position, and compatibility checked via automated lines and spot human audits.
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8
Final Packaging: Tubes are barcoded and batch-coded for traceability, then shrink-wrapped in sterile, tamper-evident packs.
This tightly controlled process assures
separator gel blood collection tube consistency, stability, and the highest degree of pre-analytical reliability.
[See animated video]
Product Focus: Gel Separator-EDTAK2 Tube
Key Features & Composition
- Material: Medical-grade PET barrel; advanced EDTA K2+ inert polymer gel
- Closure: Synthetic high-seal butyl rubber cap for safe, airtight retention
- Volume Options: 3ml, 5ml, 7ml, custom on request
- Gel Position Accuracy: ±1.5mm (industry-leading control) prevents remixing of layers
- Anticoagulant: EDTA K2, precisely 1.6–2.0 mg/ml blood
- Sterility: ISO 11137 Gamma PHP to 10-6 SAL
- Certificate: ISO 15189, ISO 13485, FDA-listing (USA), CE-IVD Mark
- Shelf Life: 24 months at ambient laboratory temperatures (4–24°C)
- Applications: Hematology, genetics, viral load testing, clinical pathology
Learn More About Gel Separator-EDTAK2 Tube
EDTA tube with gel separator provides unambiguous plasma/serum separation; trusted in leading molecular and genetics labs.
Tested Performance Data
Independent testing in 2023 found
Gel Separator-EDTAK2 Tubes deliver >96% plasma yield, 99% separation integrity, and demonstrated stability <6% variation in blood component analysis (n=650 across 5 international reference labs).
Reference: ISO 15189 audit report (2023), FDA/CE-lab assessment, and user feedback from LabCompare.
Serum/Plasma vs Gel Volume (5ml Tube)
Technical Indicators vs. Market Average
Technical Advantages: Why Choose Gel Separator-EDTAK2 Tube?
- Enhanced Separation: Premium inert gel delivers one-step separation of plasma or serum, minimizing cell debris and hemolysis.
- High Chemical Stability: PET/EDTA system ensures no sample contamination; compliant with EN ISO 6710 & FDA IVD standards.
- Extended Shelf Life: 24 months functional stability—ahead of conventional separator tube norms.
- Precision Additive Control: 6-sigma dosing of EDTA K2 guarantees consistent anticoagulation.
- Broad Compatibility: Applicable across hematology, genetics, viral diagnostics, biobanking, and research institutions.
- Global Certification: Recognized by ISO, FDA, CE-IVD—ensuring international regulatory compliance.
- Sustainability: Tubes are recyclable, produced in low-carbon facilities.
Leading-edge serum separator tube technology for reliable sample analysis at an optimized price point.
Vendor Comparison: Separator Tube Manufacturers
Attribute |
Gel Separator-EDTAK2 (B.D.T Corp.) |
Greiner Bio-One |
BD Vacutainer |
ImproMed |
Certification |
ISO 15189, ISO 13485, FDA, CE-IVD |
ISO 13485, CE-IVD |
ISO 9001, FDA |
CE, ISO 13485 |
Customization |
Yes (size, label, additive) |
Limited (label only) |
No |
Yes |
Minimum Order |
1000 pcs |
2000 pcs |
5000 pcs |
1000 pcs |
Serum Separator Tube Price (per 1000 units) |
$62–78 |
$78–92 |
$83–89 |
$75–87 |
ISO Compliance |
ISO 6710, ISO 15189 |
ISO 6710 |
ISO 6710 |
ISO 6710 |
OEM/ODM |
Support |
No |
No |
Support |
Lead Time |
12–18 Days |
24–30 Days |
21–28 Days |
21 Days |
Global Distribution |
85+ countries |
60+ countries |
100+ countries |
45+ countries |
B.D.T Corp.’s Gel Separator-EDTAK2 Tube consistently outperforms in price, customization, and regulatory support—guaranteeing swift delivery and full ISO/FDA traceability.
Customization & OEM Options
- Tube volumes (2ml–10ml), color-coded caps, private label and barcoding
- Specialty additives (EDTA K2/K3, lithium heparin, sodium citrate)
- Custom sticker/label, packaging (bulk/individual), vacuum level
- Accelerated delivery: 12–18 days for OEM/ODM orders, with rapid prototyping for critical research clients
- Batch-level certificate of analysis and compliance documents
For rapid project collaboration, extensive R&D data sharing (ISO audits, performance data), and global logistics support, please contact our engineering team.
Application Scenarios & Case Studies
Case 1: National Reference Laboratory, Southeast Asia
- Scope: Transitioned to separator gel blood collection tube (Gel Separator-EDTAK2) across all departments
- Result: 16% increase in analysis throughput; sample integrity improvement confirmed in ISO 15189 validation
- Feedback: "Contributes to faster diagnostics and better patient outcomes—especially in viral load and HbA1c testing" (Lab Director, 2023)
Case 2: Biotech Genomics Center, Europe
- Application: EDTA plasma separator tube used for ultra-pure DNA/RNA extraction
- Outcome: Downstream PCR inhibition reduced by 23% vs previous tubes due to superior plasma separation
- Industry Reference: Nature Scientific Reports (2022)
Case 3: Metropolitan Hospital, North America
- Role: Adoption of EDTA tube with gel separator for emergency coagulation testing and high-throughput clinical chemistry
- Impact: Hemolysis rate dropped by 2.5x; critical result turnaround accelerated by 18%
Professional FAQs: Separator Gel Blood Collection Tubes
1. What materials are used in separator gel blood collection tubes?
The tubes are typically made from high-grade PET or borosilicate glass with an inert, non-toxic polymer separator gel. This gel is specially formulated to maintain stability during centrifugation and prevent interaction with biological samples.
2. What standards do these tubes comply with?
Major standards include ISO 13485 (medical device QMS), ISO 15189 (lab quality/competence), EN ISO 6710 (single-use container111s for blood specimens), and FDA 21 CFR 820. These ensure tube traceability, sterility, and analytical performance.
3. How are serum/plasma and cellular components separated?
Upon centrifugation, the density-matched gel forms a barrier between serum/plasma (top) and blood cells (bottom), enabling clean pipetting for diagnostic analyses without cross-contamination.
4. What is the typical shelf life and how should tubes be stored?
Shelf life ranges from 12 to 24 months depending on the product and storage conditions (generally 4–24°C, away from sunlight). The Gel Separator-EDTAK2 Tube offers a 24-month shelf life, validated in stability tests.
5. What is the optimal centrifugation condition?
For the Gel Separator-EDTAK2, 1500–2200g for 8–10 minutes is recommended. This ensures complete phase separation while preserving biomolecule integrity.
6. How is additive (EDTA K2/K3) accurately dosed?
Precision CNC-machined dosing heads and gravimetric controls achieve an accuracy of ±0.2 mg/ml, verified through batch-release chemical analysis, per ISO 6710.
7. Are custom labels and barcoding available?
Yes, OEM/ODM services include custom labeling, barcoding (GS1/UDI), colored closures, and even regional language compliance on request.
Order Process, Warranty, and Support
- Lead Time: 12-18 working days for standard specifications, separator tube customization may extend timelines
- Warranty: 24-month shelf life guarantee, backed by full batch traceability, regulatory documents supplied with every shipment
- Customer Support: 7x24h expert support for technical questions, compliance documentation, and rapid replacement in the event of quality deviations
- Certificates: All products accompanied by IVD Declaration, ISO 15189, ISO 13485, FDA listing where relevant
Conclusion & Industry Resources
In summary, the separator gel blood collection tube market is defined by high-performance materials, rigorous manufacturing, strict adherence to international standards, and user-driven customization. The Gel Separator-