Medical Device for H-Pylori Infectious Disease Home Test (Cassette)

• Customization: Available
• Type: IVD Reagent, Test Strips & Test Tube
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Model NO.: DNSPG28
• Group: Adult
• Material: Plastic and Paper
• Logo Printing: OEM
• Package: 40/Box, 2000/Carton
• Types: Strip/Cassette
• Shipment: by Air or by Sea
• Specification(mm): Strip: 2.5, 3.0; Cassette: 3.0, 4.0
• Transport Package: Carton
• Trademark: Diagnos
• Origin: Jiangsu, China
• HS Code: 3822001000
• Production Capacity: 1000000 Pieces/Month

Product Description

Medical device for H-Pylori infectious disease home test (Cassette)

The infection of Helicobacter pylori (H. pylori) is associated with a variety of gastro-intestinal diseases, such as stomach ulcers, chronic active gastritis and gastrointestinal adenocarcinoma.  Antibodies to H. pylori are developed in individuals infected with H. pylori as a serological response. Detecting specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection, either as an adjunct to endoscopy or as an alternative measure in symptomatic patients.  The H. Pylori Rapid Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies to H. pylori in serum/plasma/whole blood specimens. The test is to be used as an aid in the diagnosis of infection due to H. pylori.

 

Details of products

Model Number:	DNSHPG28	Brand Name:	Diagnos and OEM
Power Source:	Manual	After-sale Service:	Online Technical Support
Specimen:	Whole Blood /Serum/Plasma	Format:	Strip/Cassette
Accuracy:	99.9%	Shelf Time:	24-36Months
Quality Certification:	FSC/CE/ISO13485	Warranty:	2 years

Product Information



Test Procedure 

1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. For Strip Test: Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the MAX (maximum) line. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent  surface (e.g., mouth of the serum container).
3.  For Cassette Test: Drip 2 or 3 drops of specimen into the sample well.
4. Wait 10-15 minutes and read result. Do not read results after 30 15 minutes.                                                    

Interpretation of Results
1. Negative: Only one pink band appears on test region. This indicates that there is no detectable Syphilis in the specimen.
2. Positive: Two pink bands appear on test region. This indicates that the specimen contains detectable amount of syphilis.
3. Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.

 

Storage and Stability 



Packing & Delivery

1.Strip:MOQ of 5000pcs,1 test and 1 desiccant in a single pouch,5000pcs packed one carton;
   Cassette:MOQ of 2000pcs,1 test and 1 desiccant in a single pouch,2000pcs packed one carton;

2. Shipping methods: By sea or by air.
 

Company Profile


Our Advantages:



FAQ
Q1.What's the method you use to do the test?
A: Colloidal Gold Method.

Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.

Q3: What's ur packing of the tests?
A: If you choose the low cost, we will suggest u the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.

Q4: What's the main differences when comparing products from different suppliers?
A: You can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.

Q5: How can i distinguish a good test kit?
A: You can judge from the 4facts:
1.Technical data: Such as the accuracy, specificity and sensitivity.
2.Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of
antibodies labeled on NC membrane. Shelf life will be shorten down.
3. Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
4. Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.

 

Q6: How can I get some samples?

1.We may provide some samples, but the postage and samples fee will be paid by yourself. The post charges and samples fee will be deducted from payment for goods after we bargained on the order .

2. You can give us your collect account (just like DHL, UPS etc) and detail contact information. Then you can pay the freight direct to your local carrier company.

Contact Us

Promise: Great Service is our mission, high quality is our obligation! As we strongly believe that QUALITY and SINCERE are very important among business trip !

Welcome to enquiry!

Contact Name:Lyn Fang
E-mail:sale10@diagnosbio. com