Snibe MAGLUMI FSH (CLIA)

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Product Details:

Frequency Dependent on analyzer protocol
Accuracy High accuracy, as per manufacturers insert (typically CV <10%)
Shelf Life 12 months from date of manufacture
Function Detection & Quantification of Follicle Stimulating Hormone (FSH)
Instruments Type Automated Immunoassay System (for use with MAGLUMI analyzers)
Storage Instructions Store at 28C. Do not freeze.
Display Type Dependent on analyzer (digital display)
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Snibe MAGLUMI FSH (CLIA) Price And Quantity

Snibe MAGLUMI FSH (CLIA) Product Specifications

Color Colorless to light yellow liquid
Measurement Range 0.1200 mIU/mL (refer to IFU for exact range)
Usage Type Single Use Reagent Kit
Voltage Dependent on analyzer model
Weight Depends on Kit Size (typically <1 kg per kit)
Features High sensitivity and specificity; ready-to-use reagents; automated processing
Portable Laboratory Use, Not Portable
Real-Time Operation Yes
Condition New
Accuracy High accuracy, as per manufacturers insert (typically CV <10%)
Power Source Analyzer Driven (Electricity)
Shelf Life 12 months from date of manufacture
Technology Chemiluminescence Immunoassay (CLIA)
Instruments Type Automated Immunoassay System (for use with MAGLUMI analyzers)
Function Detection & Quantification of Follicle Stimulating Hormone (FSH)
Equipment Type Immunoassay Analyzer Reagent
Use For quantitative determination of FSH in human serum or plasma
Storage Instructions Store at 28C. Do not freeze.
Power Consumption Dependent on analyzer model
Display Type Dependent on analyzer (digital display)
Operating Type Automatic with compatible analyzer
Dimension (L*W*H) Reagent Vials Standard Size (Varies with pack)
Material Diagnostic Grade Reagents and Consumables
Wall Mounted No
Frequency Dependent on analyzer protocol

Assay Time Approximately 30 minutes per run
Sample Type Human serum or plasma (EDTA, Heparin, Citrate)
Throughput High throughput with compatible MAGLUMI analyzers
Compatibility Specifically for Snibe MAGLUMI series analyzers
Regulatory Status CE marked, IVD certified
Kit Components MAGLUMI FSH reagent vials, calibrators, controls, and product insert
Pack Size 100 Tests/Kit (other pack sizes may be available)
Instruction For Use Refer to kit insert for detailed assay procedure
Intended Users Professional Laboratory Personnel
Standardization Calibrated against WHO international standard for FSH
Lot Traceability Each kit is lot traceable for QC

Product Description

Brand	Snibe
Sample Type	Serum
Fertility Marker	100T
CAT No.	130252001M
Application	Fertility Marker

The kit has been designed for the quantitative determination of follicular-stimulating hormone (FSH) in human serum. The method can be used for samples over the range of 0.5-400.0 mIU/ml. The test has to be performed on the Fully-auto chemiluminescence immunoassay (CLIA) analyzer MAGLUMI (Including Maglumi 600,Maglumi 1000,Maglumi 1000 Plus, Maglumi 2000,Maglumi 2000 Plus,Maglumi 3000 and Maglumi 4000).

High Sensitivity and Specificity

The MAGLUMI FSH (CLIA) kit is engineered for robust performance in quantifying FSH levels with outstanding sensitivity and specificity. It deploys chemiluminescence immunoassay technology, resulting in accurate and reliable results. The kit's design ensures minimal cross-reactivity and interference, supporting precise clinical diagnostics for fertility assessment and reproductive health evaluation.

Automated and Efficient Workflow

Optimized for high-throughput laboratories, this assay is fully compatible with Snibe MAGLUMI series analyzers. Ready-to-use reagent vials enable streamlined, real-time automated processing. Each test run can be completed in approximately 30 minutes, improving laboratory efficiency without compromising accuracy. The kit is ideal for labs seeking rapid turnaround and reduced hands-on time.

Comprehensive Quality Control and International Standards

Each FSH kit comes with calibrators, controls, and is lot-traceable to ensure consistent performance. It is standardized against the WHO international reference for FSH, enhancing result reliability and comparability. Detailed instructions in the product insert guide laboratory professionals through setup, operation, and interpretation, reinforcing high-quality diagnostics.

FAQ's of Snibe MAGLUMI FSH (CLIA):

Q: How is the Snibe MAGLUMI FSH (CLIA) kit used in the laboratory?

A: The kit is intended for the quantitative determination of FSH in human serum or plasma using the MAGLUMI series immunoassay analyzers. Laboratory professionals should follow the detailed instructions in the product insert for sample preparation, loading reagents, and running the automated assay.

Q: What types of samples can be tested with this FSH kit?

A: The MAGLUMI FSH (CLIA) kit is validated for use with human serum or plasma samples. It supports testing of plasma prepared with EDTA, Heparin, or Citrate anticoagulants, enabling flexible application depending on available sample types.

Q: When will I receive results after starting the assay?

A: Each assay run takes approximately 30 minutes on compatible MAGLUMI series analyzers. This rapid turnaround supports timely clinical decision-making and efficient laboratory workflows.

Q: Where can the MAGLUMI FSH (CLIA) kit be used?

A: This kit is designed for use exclusively in professional laboratory environments equipped with Snibe MAGLUMI automated immunoassay systems. It is not intended for point-of-care or portable testing.

Q: What benefits does the FSH (CLIA) kit offer over manual methods?

A: Benefits include automated processing with high sensitivity and specificity, reduced hands-on time, lot traceability for quality assurance, and adherence to international WHO standards, providing reliable and reproducible results for fertility and reproductive health assessments.

Q: How should the kit be stored for optimal performance?

A: Store all kit components at 2-8C, avoiding freezing. Follow the storage instructions in the kit insert to maintain reagent integrity and ensure accurate performance throughout the stated 12-month shelf life.

Q: What is included with the MAGLUMI FSH (CLIA) kit, and how many tests can be performed?

A: Each kit includes MAGLUMI FSH reagent vials, calibrators, controls, and a product insert, and is typically configured for 100 tests. Other pack sizes may also be available depending on supplier.

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