David CE 510K Canada urine HCG Pregnancy Test

Product Overview

Description

HCG PREGNANCY TEST 

 

The One Step hCG test is a rapid test to detect the presence of HCG in urine or serum specimens in a qualitative format sensitive to 15mIU HCG/ml. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated level of HCG in urine or serum. The immunological specificity of the test virtually eliminates cross reactivity interferences from the structurally related glycoprotein hormones hFSH, hLh, hTSH at physiological levels.

 

Key Features:

 

Easy to use 

Easy to read
Able to test any time of day
Detect pregnancy as early as 1 day after the missed period
Room temperature storage

Sample free, freight collect

 

Specifications:

1) Specimen: urine; serum/urine
2) Format: strip, cassette, midstream
3) Sensitivity: 15mIU/mL
4) One kit includes 1 test (with desiccant) in a foil pouch

 

Inter packing:
1) Strip:	100 pcs/bag
2) Cassettes:	50 pcs/bag
3) Midstream:	50 pcs/bag
Outer packing:
1) Strip:	50 bags/ctn/ 51 x 35 x 47cm
2) Cassettes:	50 bags/ctn/ 58 x 45 x 43cm
3) Midstream:	40 bags/ctn/ 58 x 45 x 51cm

 

 

 

 

 

 

 

 

 How to operate the test

 

1. When you are ready to begin testing, open the foil pouch by tearing along the notch. Remove the test and take off the cap.

2. With the test pointing downwards hold the absorbent sampler in your urine stream for 2-3 seconds (please do not stream pass the arrow end and taking care not to splash the window.)You may then wish to replace the cap. 3. Hold the test for a few seconds or lay the test flat. When you see the urine pass the show window and red line appear, the test is complete and has worked correctly. Read the result in 5 minutes but no longer than 15 minutes.

Note: Any urine specimen is appropriate for the HCG test midstream, but if you have just begun your pregnancy, the first morning urine is optimal.

 

 

How to read the results

 

*Negative: If there is only one red line in the show window, it means that you are not pregnant.

*Positive: If there are two red lines appear in the show window, it means that you are pregnant.

*Invalid: A total absence of red lines in the show window is an indication of procedure error and/or that test reagent deterioration has occurred.

 

 

 

 

Company Information  

 

Founded in 2001, Equinox Biotech Co., Ltd. is located in the China and Israel Science and Technology Innovation Cooperation Zone (Shantou) covering an area of 20,000 square meter.

We have gotten CE and ISO 13485 certificates. Our production management is strictly in accordance with the international quality management system to ensure product quality.

Relying on the advantages of talents and technology, we have established a perfect industrialization system of R&D, production and marketing in the field of bio diagnosis, which provides a powerful driving force to the company's sustainable development.

We have world-leading production lines and experienced staffs with a daily production capacity of 2 million test kits.

Our main products are rapid diagnostic kits covering areas like fertility diagnosis, drug of abuse detection, rapid diagnosis of infectious diseases and tumor detection. At present, we have obtained 510 (k) approval, Health Canada approval and CE certification for some of the products. Because of excellent quality, such as good reproducibility and specificity, high sensitivity and easy operation, and competitive price, they are favored by customers from the United States, Europe, Africa, Middle East, Asia, South America, South Asia and other international markets.

We are committed to providing people with products and services of outstanding quality, thus making their lives easier and more convenient.

 

 

 

OEM Capability 

EQUINOX also provides customized client services for distributors and manufacturing partners. 
The production starts from raw materials and the product can be customized at any step of production. We can also provide packaging and supplies such as boxes, product shape and formats, uncut sheets, pouch printing services, and any other product modification that suits client's marketing needs. Please contact our sales and marketing team in order to obtain more information on OEM capabilities.