CE/510K/ISO David OEM Быстрый и легкий тест на беременность

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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


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







Runbio 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.



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