What is the accuracy of the test?

The test achieves an accuracy rate between 97.50% and 99.47%.

How long does it take to get results?

Results are available as fast as 2 to 15 minutes.

What samples can be used?

It supports human whole blood, serum, or plasma.

Is the product in stock?

Yes, the product is in stock and ready to ship immediately.

What is the warranty period?

The product comes with a two-year quality guarantee period.

Can the product be customized?

Yes, full customization options are available for this product.

What is the minimum order quantity?

The minimum order quantity is 10 pieces.

What are the payment terms?

We accept LC, T/T, D/P, PayPal, Western Union, and small-amount payments.

97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology

Hangzhou Singclean Medical Products Co., Ltd.

11 yrs

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Product Highlights

High Accuracy Rate: Achieves 97.50% to 99.47% accuracy for rapid auxiliary diagnosis.
Fast Results: Delivers results in just 2 to 15 minutes for quick decision making.
High Sensitivity: Over 95% sensitivity and specificity for reliable detection.
Ready to Ship: Products are in stock and ready for immediate dispatch.
Two-Year Warranty: Comes with a two-year quality guarantee period for peace of mind.
No Equipment Needed: All necessary reagents provided; no external equipment required.
Flexible Customization: Offers full customization options for specific testing needs.

Product Attributes

Customization: Available
Type: Test Strips & Test Tube
Material: Plastic
Model NO.: 2019
Quality Guarantee Period: Two Years
Group: All
Use: Detection of Igg and Igm Antibodies to 2019 Novel
Speciems: Human Wholeblood, Serum or Plasma.
Packing: Box and Carton
Shipment: by Air or by Sea
Feature 1: Fast Results in 2-15 Minutes
Feature 2: Over 95% Sensitivity and Specificity
Feature 3: Have Stock, Ready to Ship
Transport Package: Carton or Customized Package
Specification: 1 test/box; 20 test/box;
Trademark: Singclean or Customized brand
Origin: China
HS Code: 3002190000
Production Capacity: 10000/Day

97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology pictures & photos — 97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology

97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology

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97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology

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Product Description

97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology

IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 V-ir-0us in human wholeblood, serum or plasma.

The fast test cassette, part of the kit, can detect the virus in just 10-15 minutes.

The test kit can shorten the testing time, provide easier and faster operation and make rapid diagnosis of suspected patients and on-site screening of people in close contact.
97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology
MATERIALS SUPPLIED
20 sealed pouches each containing a test cassette, a dropper and a desiccant
Buffer
1 package insert
1 alcohol pad for disinfection use
1 Lancet (for fingerstick whole blood only)

MATERIAL REQUIRED BUT NOT PROVIDED
1. Centrifuge (for plasma only)
2. Timer
3. Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning.

Features & Benefits
• Fast results as soon as 2-15 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• Little specimens, only 5 μL of serum/plasma or 10 μL of whole blood specimens
• All necessary reagents provided & no equipment needed
• High sensitivity and specificity

Product Comparison

97.50% -99.47% Accuracy Rapid Testing for Auxiliary Diagnosis in Rapidmicrobiology

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.

Hangzhou Singclean Medical Products Co., Ltd.

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
QA/QC inspectors: 66 people
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
New Products Launched in Last year: Yes

Our Certifications, Standards & Industry Recognition

Management System Certification: ISO9001:2015, Others
Cooperated with Fortune 500: No

FAQ

What is the accuracy of the test?: The test achieves an accuracy rate between 97.50% and 99.47%.
How long does it take to get results?: Results are available as fast as 2 to 15 minutes.
What samples can be used?: It supports human whole blood, serum, or plasma.
Is the product in stock?: Yes, the product is in stock and ready to ship immediately.
What is the warranty period?: The product comes with a two-year quality guarantee period.
Can the product be customized?: Yes, full customization options are available for this product.
What is the minimum order quantity?: The minimum order quantity is 10 pieces.
What are the payment terms?: We accept LC, T/T, D/P, PayPal, Western Union, and small-amount payments.