Class II Pathological Analysis Equipments One Step Medical Diagnostic Rapid Test

Class II Pathological Analysis Equipments One Step Medical Diagnostic Rapid Test

Product parameters:

NTRODUCTION
For whole blood:

Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should be refrigerated at 2-80C.

Freezing is recommended if the storage periods are more than 3 days. They should be brought to room temperature before testing.

Using the specimen after long-term storage of more than three days can cause non-specific reaction. When stored at 2-8 0C, the whole

blood sample should be used within three days.

ASSAY PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: For whole blood sample: Fill the dropper with the specimen then add 1 dropper of specimen(about 10uL).

Then add 2 drops (about 60-100 μL) of Sample Diluent immediately into the sample well (S well)

Step 4: Read the result within 15 minutes. Don’t read results after 30 minutes.

Negative

Only the C band shows color development. The T band shows no color development.

Positive

Both C and T bands show color development.

The appearance of any burgundy color in the T band, regardless of intensity, must be considered as presence of the band.

Invalid:

If no C band is developed, the assay is invalid regardless of color development on the T band as indicated below. Repeat the assay with a new device.

PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use test kit beyond expiry date.

3. The test device should not be reused.

The purpose of the development of pathological analysis paper is to diagnose patients quickly, conveniently and
accurately.Now pathological analysis paper has been widely used in the world, not only self-test, but also in hospitals
and centers for disease control and prevention.The accuracy rate of a single pathological analysis paper is more
than 95%. If the results of two or more tests of different brands of test paper are the same, the test results can be
considered as 99% accurate.

Newlystar (Ningbo) Medtech Co.,Ltd. is one of the leading supplier for Pathological Analysis Equipments,
Diabetes Treatment Equipment and Finished Pharmaceutical from China. With a proven track record of
passed years,Newlystar-Medtech has been recognized by her customers as a high-quality and reliable
supplier notonly on products, but also on assistance for audit and improvement of GMP level, quality
management system, EHS management system and registration dossier support, etc.The essence of
Newlystar-Medtech's activites, is a commitment to her customers with professional service and high-quality
products with effective cost and innovative solutions.
All medical product work in Newlystar-Medtech like a bridge link the customers and Chinese manufacturers,
especially, their professional working is to make the formulation manufacturers who is familiar with
Chinese medical product to understand well the international requirement,to ensure the success of customers.
The advantages on professional working and strongly representative base on first-class manufacturing partners
in China, enable Newlystar-Medtech to provide her customers with a wide range and high-tech products,
best services and capabilities for their actions in tender, distributing and improvement in their national healthcare
system. Newlystar-Medtech also dedicates herself to sourcing quality medical products for Chinese market.

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