Snibe MAGLUMI D-dimer (CLIA)

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Product Details:

Instruments Type MAGLUMI Immunoassay Analyzers
Usage Type Laboratory/Clinical
Shelf Life 12 months
Storage Instructions 28C, avoid freezing
Measurement Range 0.05 20 mg/L FEU
Function Diagnosis/exclusion of thromboembolic events such as DVT and PE
Accuracy Meets IFCC performance criteria; CV 6%
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Snibe MAGLUMI D-dimer (CLIA) Price And Quantity

Snibe MAGLUMI D-dimer (CLIA) Product Specifications

Wall Mounted No
Weight As per kit size
Power Source N/A (analyzer-dependent)
Storage Instructions 28C, avoid freezing
Display Type N/A (display via analyzer)
Features High sensitivity and specificity, rapid throughput, traceable calibrators, onboard stability
Shelf Life 12 months
Usage Type Laboratory/Clinical
Operating Type Automated (requires MAGLUMI immunoassay analyzer)
Color White/transparent reagent vials
Portable No, analyzer-based
Condition New
Measurement Range 0.05 20 mg/L FEU
Use Quantitative determination of D-dimer in human plasma
Function Diagnosis/exclusion of thromboembolic events such as DVT and PE
Equipment Type D-dimer Reagent Kit (CLIA)
Instruments Type MAGLUMI Immunoassay Analyzers
Real-Time Operation Yes, compatible with MAGLUMI system
Accuracy Meets IFCC performance criteria; CV 6%
Material IVD-grade reagent, biological buffers, chemical reagents
Dimension (L*W*H) Kit packaging as per manufacturers standard
Technology Chemiluminescence Immunoassay (CLIA)

Test Time Within 30 minutes
Package Content Reagent kits, calibrators, controls, instructions
Sample Type Human plasma (citrate/EDTA)
Intended Users Clinical laboratories, diagnostic centers
Regulatory Status CE-IVD, ISO 13485 certified
Throughput Up to 180 tests/hour (analyzer-dependent)

Product Description

Brand	Snibe
Sample Type	Serum
Pack Size	100T
CAT No.	130206008M
Application	Cardiac Marker

The kit has been designed for the quantitative determination of D-dimer in human plasma (suggested). The method can be used for samples over the range of 0-100 g FEU/ml. The test has to be performed on the MAGLUMI chemiluminescence immunoassay (CLIA) fully auto analyzer (Including MAGLUMI 1000, MAGLUMI 2000, MAGLUMI 2000 Plus and new developed models).

Rapid and Reliable D-dimer Measurement

The Snibe MAGLUMI D-dimer (CLIA) kit enables swift and dependable quantification of D-dimer in human plasma. Ideal for urgent diagnostic needs, the system streamlines testing with automated processing and results available in under 30 minutes. This efficiency supports prompt clinical decisions regarding the exclusion or diagnosis of thromboembolic disorders such as DVT and PE.

High-Throughput and Automation

Tailored for busy clinical settings, the kit supports up to 180 tests per hour-making it suitable for high-volume laboratories. Integration with MAGLUMI analyzers ensures seamless, hands-free operation, reducing human error and increasing workflow efficiency. The reagent vials are designed for stability and easy loading, further optimizing laboratory productivity.

Certified Quality and Performance

With CE-IVD marking and compliance with ISO 13485 standards, the Snibe MAGLUMI D-dimer (CLIA) kit offers assured quality and traceability. The included calibrators and controls ensure every run meets stringent precision criteria (CV 6%) and adheres to IFCC-approved measurement ranges. Each kit is shipped with full documentation and easy-to-follow instructions.

FAQ's of Snibe MAGLUMI D-dimer (CLIA):

Q: How is the Snibe MAGLUMI D-dimer test performed in a laboratory setting?

A: The D-dimer test is conducted by loading human plasma samples (citrate or EDTA) onto a MAGLUMI immunoassay analyzer along with the reagent kit. The process is fully automated-requiring minimal manual steps-and delivers quantitative results within 30 minutes.

Q: What clinical conditions can the Snibe MAGLUMI D-dimer kit help diagnose?

A: This kit is designed for the diagnosis and exclusion of thromboembolic events, particularly deep vein thrombosis (DVT) and pulmonary embolism (PE), by measuring D-dimer concentrations in plasma.

Q: When should laboratories run D-dimer testing using this kit?

A: Laboratories typically use this D-dimer kit when physicians suspect thromboembolic disorders or need to rule out conditions like DVT and PE quickly. It is suitable for routine or urgent diagnostic workflows.

Q: Where can the Snibe MAGLUMI D-dimer kit be used?

A: The kit is intended for use in clinical laboratories and diagnostic centers equipped with MAGLUMI immunoassay analyzers. It is not designed for point-of-care or home use.

Q: What are the benefits of using the MAGLUMI D-dimer kit over other methods?

A: Key benefits include its high sensitivity and specificity, rapid throughput (up to 180 tests/hour), automated operation, and traceable calibrators for accurate results. Its robust onboard stability and flexible measurement range further enhance laboratory efficiency.

Q: How should the reagent kit be stored to maintain stability?

A: The D-dimer reagent kit should be stored at 2-8C in accordance with manufacturer guidelines. Avoid freezing the reagents to preserve their performance throughout the 12-month shelf life.

Q: What materials and components are included in each package?

A: Each kit contains IVD-grade reagents, biological buffers, chemical reagents, calibrators, controls, and a comprehensive instruction manual. Packaging size and weight vary by kit version.

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