CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid Pregnancy Test

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CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid Pregnancy Test

CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid 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

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DESCRIPTION

Basic Info
Model NO. RH-HCG-M
Format Strip /Cassette /Midstream
Certificate Ce/ISO13485/FDA
Specification 4.0mm/6.0. mm
Trademark DAVID, RUNBIO, OEM
Origin Shantou, 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

CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid Pregnancy Test

CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid Pregnancy Test

CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid Pregnancy Test

CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid Pregnancy Test


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.

CE FDA/510K Mdsap Approval OEM Medical Supply David One Step Rapid Pregnancy Test

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.