Medical HCG Pregnancy Virus Antigen Antibody Troponin Dengue HP HBV Hbsag Rapid Blood Glucose HCV Antibody HIV Malaria PF Elisa Urine Test Kit Cassette Strip

Short Description:

Product Description

Test Procedure:
Allow the test kit and specimen to equilibrate for room temperature prior to testing
1. Remove the cassette from te foil pouch.
2. Using the plastic pipettor provided,draw about one drop of specimen into the sample well of the kit.
3. Then fraw one drop of butter into the sample well as well.
4. Read ressults at 15 minutes.

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Description

H.pylori Antigen Test KitH.pylori antigen detection in stool is a rapid, non invasive, easy to perform test that can be used to detect active infection, monitor effectiveness during therapy and to confirm cure after antibiotic use. The ease to collect the specimen, especially in children, in whom endoscopy would be difficult and the non requirement of specially trained staff to collect and perform the test adds to the tests advantage. Also, prior preparation of the patient is not necessary unlike in upper gastrointestinal endoscopy.

Product Principle

The coVID-19 lgM/lgG antibody rapid test is a fast and effective method forscreening lgM and lgG antibodies against SARS-CoV-2.This test can alsosuggest information on the stage of infection.

Both lmmunoglobulin M(IgM) and lmmunoglobulin G (IlgG) antibodies areproduced during the primary immune response.As the body's largestantibody, lgM is the first antibody to appear in response to an initialexposure to antigens.lgM provides the first line of defence duringviral infections, followed by the generation of adaptive, high affinitylmmunoglobulin G (lgG) responses for long-term immunity andimmunological memory.lgG is usually detectable about 7 days afterthe lgM appears.

Specification

Product name	H.pylori Antigen Test Kit
Size	3.0mm/4.0mm
Speciemn	Fecal, stool
Format	Cassette type
Packing	20 tests per box; 25 tests per box
Usage	Medical using, hospital using, home nursing, etc
Certificate	ISO13485
Service	OEM & ODM availbale

Product Use

1.Prepare the Test
Allow the test cassette toreach room temperature,use it within 20 minutes after opening the pouch.

2.Add the Spercimen
Add 10Ul of whole blood,serum or plasma specimen
Add two drops of Dilluent Buffer.

Product Details

1.Performance: sensitivity of 94.70% (125/132) and specificity of 98.89%02 (268/271).The test has been clinically validated during the 2020 COVID-19 outbreak in China.

2.Sample Type: whole blood sample, serum and plasma

3.Detection Method: Colloidal Gold

4.Detection Time: 10 - 15 minutes

5. Not suitable for Point of Care Testing

6.CE Certified

Each Box Contains:
20x Individual sealed pouches (1x Test cassette, 1x Desiccant pouch), 20x disposable pipettes, sample diluent and instructions for use (IFU).

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Regulatory:

ISO13485

Standard:

EN ISO 13485 : 2016/AC:2016 Medical equipment quality management system for regulatory requirements
EN ISO 14971 : 2012 Medical devices - Application of risk management to medical devices
ISO 11135:2014 Medical device Sterilization of ethylene oxide Confirmation and general control
ISO 6009:2016 Disposable sterile injection needles Identify color code
ISO 7864:2016 Disposable sterile injection needles
ISO 9626:2016 Stainless steel needle tubes for the manufacture of medical devices

Teamstand Company Profile

SHANGHAI TEAMSTAND CORPORATION is a leading provider of medical products and solutions.

With over 10 years of healthcare supply experience, we offer a wide product selection, competitive pricing, exceptional OEM services, and reliable on-time deliveries. We have been the supplier of the Australian Government Department of Health (AGDH) and the California Department of Public Health (CDPH). In China, we rank among the top providers of Infusion, Injection, Vascular Access, Rehabilitation Equipment, Hemodialysis, Biopsy Needle and Paracentesis products.

By 2023, we had successfully delivered products to customers in 120+ countries, including the USA, EU, Middle East, and Southeast Asia. Our daily actions demonstrate our dedication and responsiveness to customer needs, making us the trusted and integrated business partner of choice.