Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury
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Product Highlights
- Early Diagnosis Capability: Aids in early diagnosis of acute kidney injury and risk classification.
- High Sensitivity: Detects NGAL levels as low as 10ng/ml with high accuracy of 98%.
- Wide Linear Range: Measuring range spans from 5 to 300ng/ml for versatile testing needs.
- Small Sample Requirement: Requires only 5ul of urine sample for accurate quantitative determination.
- Rapid Assay Time: Delivers results in approximately 10 minutes for rapid decision making.
- Long Shelf Life: Valid for 24 months from manufacturing with 4 weeks stability after opening.
- Multiple Sample Types: Compatible with urine, EDTA plasma, and heparin plasma samples.
- Full Customization: Offers full customization options including OEM and ODM services.
Product Attributes
- Customization
- Available
- Type
- IVD Reagent, Test Strips & Test Tube
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Model NO.
- NGAL
- Quality Guarantee Period
- Two Years
- Group
- Adult
- Material
- Elisa Kit
- Function
- Early Diagnosis of Acute Kidney Injury
- Company
- Manufacture
- Transport Package
- Color Box
- Specification
- 50pcs/box
- Trademark
- Singclean
- Origin
- China
Product Images of Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury
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Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury -
Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury -
Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury -
Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury -
Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury -
Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury -
Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury
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Product Description
Ngal Elisa Kit (human) Ce Ivd for Early Diognosis Kidney Injury
The NGAL Test™ is a particle-enhanced turbidimetric immunoassay for the quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine, EDTA plasma or heparin plasma on automated clinical chemistry analyzers. NGAL measurements are useful in the diagnosis of acute kidney injury which may lead to acute renal failure.
One Step Test for NGAL (Colloidal Gold) applies colloidal gold Immunol Chromatography, for the qualitative detection of Neutrophils Gelatinase Associated Lipocalin (NGAL) in human urine specimen. This test is used as an aid in the early diagnosis of acute kidney injury, risk classification and treatment monitoring.
Assay specifications
| Method | Particle-enhanced turbidimetric immunoassay (PETIA) |
|---|---|
| Sample | Urine, heparin and EDTA plasma |
| Number of tests | Approx. 100 (Can vary based on analyzer model) |
| Assay time | Approx. 10 minutes |
| Measuring range | 25 to 5,000 ng/mL |
| Shelf life | 24 months from manufacturing. See expiry date on the label |
| Stability after opening | 4 weeks at 2-8°C. On the Hitachi 917 analyzer, the manufacturer obtains satisfactory performance for up to 8 weeks. |
| On board stability | 4 weeks at correct temperature (2-8°C) in appropriate containers. On the Hitachi 917 analyzer, the manufacturer obtains satisfactory performance for up to 8 weeks on board |
| Sample stability | If testing after 24 hours of sampling, freeze samples at -20°C or below. For long-term storage of specimens, -70°C or below is recommended |
| Application | IVD - in vitro diagnostic use* |
Assay procedure
The assay should be carried out in accordance with the specific application note for the chemistry analyzer to be used.
Clinical application
Measuring NGAL in urine or plasma gives you information on AKI status that you need for rapid decision making e.g. in the following settings -
- Intensive care - monitoring
- Emergency room - triage tool
- Cardiopulmonary bypass surgey - monitoring
- Renal transplantation - predictive evaluation
- Intravenous contrast agents - assessing nephrotoxicity
Method patented/patent pending in selected countries.
FEATURES
High sensitivity: 10ng/ml
High accuracy: 98%
Wide linear range:5-300ng/ml
Small sample size:5ul(urine)
STORAGE
Original packaging should be stored in the 4-30 ºC, a cool, dark, dry place, frozen is avoid.
The period of validity: 24 months.
About the Supplier
This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR2532126". Items marked "
" are certified.
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Company Profile
Company Introduction
Hangzhou Singclean Medical Products Co., Ltd., established in March 2002 with registered capital of 80, 000, 000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials.With highly-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices and drug injection products of Class III that conform to the laws and regulations of National Medical Products Administration (NMPA) and EU MDR.
Cooperation
The company set up a joint research center with Zhejiang University of Science and Technology, and has well established R&D cooperation relations with Zhejiang University, Donghua University and Zhejiang University of Technology, developing four series of new products with proprietary intellectual property rights, and with a variety of high-tech products to be developed cooperatively.The company also built an R & D platform for medical biomaterials that keeps up with the international level, and made major breakthrough in many key technologies such as those for stopping bleeding, anti-adhesion, and tissue engineering basic materials, with more than 55 patents obtained and a number of products applying for the patents.
Our manufacturing
The company's plant in Xiasha covers the construction area of 174014.83 m²And producing tract of 13, 200 m²Including cleanrooms of 2, 300 m²In which cleanroom of Class C covers 2, 000 m²And that of Class B covers 300 m²With over 60 m²Of which follows into Class A.A new cleanroom up to GMP standard was set up in this plant, and the Pharmaceutical Production License was obtained in 2012.It will produce all kinds of medical equipment and medical 10 million sets, production value 2 billion, In addition, the plant has introduced more production facilities such as the Invoa filling machine from Germany, the sterilizer from GETINGE, the semi-automatic filling and sealing equipment from Pluemat, 5T / h purified water machine, 3T / h water for injection machine, and 1T / h of pure steam generator.
Quality system
Respect for life strict quality control
The company has set up a documentation-based GB/T19001-2008, YY/T0287-2003, Good manufacturing Practice for medical devices, Good manufacturing practice for In vitro diagnostic reagents, good manufacturing practice of drug, 2010, medical device directive (MDD93/42/EEC ), according to quality objectives, auit resullt, data analysis, corrective and preventive actions and management review, in order to maitain the continued suitability and effectivenss of the quality managenment system.
Technological Innovation
Cohesion of technological strength improving core competitiveness
The company has been always laid stress on product rsearch and development, investing annually 10% of the sales to comstruction of R&D center, new product development and introduction of advance equipments.The R&D center is equipped with cleanroom in Class 10000(including Class 100) of more than 200m², and it has acquired a number of patent technologies.
Product center
Committing herself to develop new types of composite and smart biomaterials, the company majors in producing biodegradable bio-materials and their derivatives, and has at present products of 8 series (chitosan, medical sodium hyaluronate gels, cross-linked hyaluronic acidsodium gels, microporous polysaccharide, oxidized regenerated cellulose, basic materials of tissue engineering, in vitro diagnostic reagents), 50 varieties of cosmetics are being exported to more than 120 countries around the world, such as:Italy, Russia, Turkey, France, Brazil, Chile, Australia, and Canada.Until now, Singclean has got 30+ CE certificates, 16 medical device registration certificates and 46 patent certificates.At Singclean, all their 600 employees are working with the best and committed to excellence.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- No. 125(E), 10th Street, Hangzhou Qiantang Area, China 310018, Hangzhou, Zhejiang, China
-
Plant Area
- 13045 square meters
-
Number of Employees
- 546
-
Registered Capital
- 80,000,000 RMB
-
Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR, EXW
-
Average Lead Time
- Peak Season Lead Time, one month, Off Season Lead Time, within 15 workdays
-
Nearest Port
- Shanghai Port
-
Minimum Order Quantity
- 10 PCS
-
Supply Chain Partners
- 260
Our Production Capability & Technical Expertise
-
Main Products
- Dermal Filler, Joint Lubrication for Knee, Cross-Linked Sodium Hyaluronate Gels, Absorbable Hemostatic Particles, Oxidized Regenerated Cellulose, Poly-L-Lactic Acid Filler For Injection
-
Production Lines
- 10
-
Production Machines
- Testing Machine
-
Inspection Type for Finished Products
- 100% inspection Visual inspection Function inspection
-
Inspection Method for Finished Products
- Finished product checked by packing staff
-
Customization Options
- Full Customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 22 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2003-03-25
-
Export Year
- Shanghai Port
-
Main Markets
- North America, Europe, Southeast Asia/ Mideast, Africa, Australia, Domestic
-
Repeat Buyers Choice
- 50%~80%
-
Number of Foreign Trading Staff
- 54
-
Overseas Agent/Branch
- Yes
Our Certifications, Standards & Industry Recognition
-
Management System Certification
- ISO9001:2015, Others
-
Cooperated with Fortune 500
- No
FAQ
- What is the primary clinical application of this kit?
- It is used for the early diagnosis of acute kidney injury, risk classification, and treatment monitoring in settings like intensive care and emergency rooms.
- What types of samples can be tested?
- The kit supports quantitative determination in human urine, EDTA plasma, and heparin plasma.
- What is the minimum order quantity?
- The minimum order quantity is 10 pieces.
- Does the manufacturer offer customization services?
- Yes, full customization is available, including OEM and ODM services.
- What is the assay time for the test?
- The assay time is approximately 10 minutes.
- What payment terms are accepted?
- Accepted payment terms include LC, T/T, D/P, PayPal, Western Union, and small-amount payments.
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