99.9% Accuracy Ce FDA 510K Home Use Pregnancy Test Strip

• Type: IVD Instrument
• Sensitivity: 10 Miu/Ml;15miu/Ml;25miu/Ml
• Accuracy: More Than 99%
• Shelf Time: 24-36 Month
• OEM Time: 15-35 Days
• Certificate: Ce/ISO13485/FDA
• Model NO.: RH-HCG
• Specimen: Urine, Serum
• Format: Strip /Cassette /Midstream
• Specification: 2.8mm/3.0mm/4.0. mm
• Trademark: DAVID, RUNBIO, OEM
• Origin: Guangdong, China
• Production Capacity: 400000 Piece/Pieces Per Day

Product Description

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

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

How to operate the test

 

 

How to read the results

*Negative: If there is only one red line appears in the control line (C), it means that you are not pregnant.

*Positive: If there are two red lines appear in the show window(both in the control line and the test line) , it means that you are pregnant.

*Invalid: A total absence of color in both lines is the indication of error procedure and/or means that test reagent deterioration has occurred.