Instructions for using Helicobacter pylori stain solution

【Product name】 Helicobacter pylori staining solution

【Model Specification】 0.25ml/piece.

【Product properties, structure and composition】 This product is composed of phenol red, urea, ethanol, purified water, etc.

【 Intended use 】 For Helicobacter pylori staining.

【Mechanism of action】 Determine whether urease is present in the sample through the detection of urease in the sample.

【Scope of application】 For staining Helicobacter pylori in samples.

【 Usage method 】

1. Sample collection method:

1.1 Scrape the inner wall of the mouth with a cotton swab for 3-5 times, then place it under the tongue for 30S, and remove it after the cotton swab is completely infiltrated.

1.2 or use a cotton swab to apply 3-5 times to the tooth/gum surface and remove.

2. Operation steps:

2.1 Sampling according to Step 1;

2.2 Place the sample in the reagent after sampling;

2.3 The liquid medicine is in full contact with the sample;

2.4 Read the result within 2 minutes.

【 Result judgment】

Negative: colorless or orange-yellow.

Positive: Red.

【 Note 】

1. This product is only used for in vitro diagnosis;

2. Observe the results within 2 minutes;

3. After smoking and eating, it can be detected by method 1;

4. The product diagnosis results are for tips only, and should be based on the diagnosis of professional medical institutions.

【 Storage conditions 】 Sealed, dark, below 35℃, stored in a cool and dry place.

【Production record Certificate Number】 E Han Food and Drug Administration equipment production preparation  No. 20230016

【Medical device product filing certificate number】E Han Instrument No. 20190774

【 Manufacturer 】 Ja Na Biotechnology (Wuhan) Co., LTD

【Case preparer】 Ja Na Biotechnology (Wuhan) Co., LTD

【Production address】 Area A A0402, R & D Building, No.666 Shendun Fourth Road, East Lake New Technology Development Zone, Wuhan City

【Record address】 Area A0402, R & D Building, No.666 Shendun Fourth Road, East Lake New Technology Development Zone, Wuhan

【Production date】 See packing box.

【 Effective period 】 Two years

【 Specification Approval and amendment Date 】2023/2/3

【 Postal Code 】430070