• FDA 510K and Ce HCG Urine Pregnancy Test
  • FDA 510K and Ce HCG Urine Pregnancy Test
  • FDA 510K and Ce HCG Urine Pregnancy Test
  • FDA 510K and Ce HCG Urine Pregnancy Test
  • FDA 510K and Ce HCG Urine Pregnancy Test
  • FDA 510K and Ce HCG Urine Pregnancy Test

FDA 510K and Ce HCG Urine Pregnancy Test

Type: IVD Instrument
Certificate: Ce/ISO13485/FDA
Specimen: Urine, Serum
Sensitivity: 10 Miu/Ml;15miu/Ml;25miu/Ml
Accuracy: More Than 99%
Format: Strip /Cassette /Midstream
Customization:

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Basic Info.

Model NO.
RH-HCG
Transport Package
Foiled Pouch
Specification
2.5mm/3.0mm/4.0. mm
Trademark
DAVID, RUNBIO, OEM
Origin
Shantou, China
Production Capacity
400000 Pieces Per Day

Product 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.
 

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
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
FDA 510K and Ce HCG Urine Pregnancy Test
FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test

FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test

FDA 510K and Ce HCG Urine Pregnancy Test
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).

FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test FDA 510K and Ce HCG Urine Pregnancy Test
 

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Plant Area
16245 square meters
Management System Certification
ISO9001:2015, ISO 13485 Certificate