CE FDA 510K Approval OEM HCG Accurate One Step Lab Pregnancy Test Kit De Test

• Certification: CE, FDA, ISO13485
• Accuracy: More Than 99%
• Sensitivity: 10 Miu/Ml;15miu/Ml;25miu/Ml
• OEM Time: 15-35 Days
• Shelf Time: 24-36 Month
• Specimen: Urine, Serum
• Model NO.: RH-HCG
• Format: Strip /Cassette /Midstream
• Certificate: CE/ISO13485/FDA/Mdsap
• Specification: 4.0mm/6.0. mm
• Trademark: DAVID, RUNBIO, OEM
• Origin: Shantou, China
• Production Capacity: 400000 Piece/Pieces Per Day

Product Description

One Step Pregnancy Test (Colloidal Gold)

· individually packed

· easy to use

· quick result

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.
 

Product name	HCG Pregnancy test
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/MDSAP
Specimen	Urine,Serum
Format	Strip /Cassette /Midstream
Size	Strip: 2.5mm/3.0mm/3.5mm/4.0mm/5mm
	Cassette :3mm/4.2mm
	Midstream:4mm/6mm
Usage	Read results within 10-15 minutes

Test Method

Strip (1) Remove the device from the sealed pouch.  (2) With arrows pointing toward the urine sample, immerse the device vertically in the urine sample for at least 10 seconds.  (3) Start timing and observe the result within 5-10 minutes.  Cassette  (1) Remove the device from the sealed pouch and lay it on a flat surface.  (2) Take out the dropper provided with the device, draw urine and then continuously add 2-3 drops into the sample well.  (3) Start timing and observe the result within 5-10 minutes.  Midstream  (1) Remove the device from the sealed pouch.  (2) Hold the handle of the device, take off the cap (if any), then directly urinate towards the absorbent tip for 2-3s. After that put on the cap (if any) and lay the device on a flat surface or keep holding it flat. The alternative method is that hold the handle of the device, take off the cap (if any), immerse the device vertically in the urine sample for at least 10 seconds. Remove the device from urine sample and lay it on a flat surface or keep holding it.  (3) Start timing and observe the result within 5-10 minutes.

 

Interpretation of Results

Positive: One red line appears in the test region (T) and another red line appears in the control region (C).  Negative: A red line appears in the control region (C) but no red line appears in the test region (T).  Invalid:No line in both the test region (T) and control region (C), or a red line appears in the test region (T) but no red line appears in the control region (C).