Urine Pregnancy Test Strip - China

Urine Pregnancy Test Strip

Port: Shanghhai

Minimum Order Quantity: 200, 000 Piece/ Pieces

Supply Ability: 500, 000 Piece/ Pieces per Week

Payment Terms: L/ C, T/ T

Packaging & Delivery

Packaging Details: 100 tests/ box or as request

Delivery Detail: 3 ~ 4 weeks

Specifications

Urine Pregnancy Test Strip

FDA 510k Approval

CE Certificate ( CE 0197)

ISO 13485 Certificate

Intended Use

The Urine Pregnancy Test Strip is an immunochromatographic

assay designed for the rapid determination of human

chorionic gonadotropin ( hCG) in urine.

The test is used to

obtain a visual qualitative result.

For in vitro self-

testing use only.

Principle

Human chorionic gonadotropin ( hCG) is a hormone, produced by

the developing placenta shortly after the conception and

secreted into the urine.

The pregnancy test contains

antibodies which specifically react with this hormone.

When the strip is immersed into a urine specimen, capillary

action carries the specimen to migrate along the membrane.

When hCG in the sample reaches the Test Zone region of the

membrane, it will form a colored line.

Absence of this

colored line suggests a negative result.

To serve as a procedure control, a colored line will appear

at the control zone region, if the test has been performed

properly.

Test Procedure

1 - Remove a Testing Device from the foil pouch by tearing at

the notch and place it on a level surface.

2 - Holding a Sample Dropper vertically, add exactly 2- 3

drops of urine specimen to the sample marked S.

3 - Read results in 5 minutes.

Do not read results after more

than 5 minutes.

Interpretation of result

Positive( Pregnant)

Both C line and T line appear in the viewing window

accordingly, indicating you are probably pregnant.

One line

may be lighter than the other, they do not have to match.

Negative ( Not pregnant)

Only one line, the C line, appears in the control region,

indicating you are probably not pregnant.

Invalid

The result is invalid if no red line appears in the control

region, even if a line appears in the test region.

You

should repeat the test with a new midstream test.

Material Provided

Each test contains:

1 - One test strip

2 - One desiccant

Each kit contains:

1 - 100 test strips

2 - 1 instruction

Company Contact:

• Posted By: Zhejiang Orient Gene Biotech Co.,LTD

• Phone: 8613671972583

• Address: 23E,No.1 2005 Alley,Huangxing Road,Yangpu District, Shanghai , China

• Email:

• Website: https://www.orientgene.com

• Business Description: Zhejiang Orient Gene Biotech Co., Ltd. is founded and puts into
  
  production in 2008 - The company, a hi tech enterprise with medical
  
  and biological technologies as pillar industry, is an important new
  
  base in China which researches and develops, produces, and sells
  
  gene diagnostic technologies centered in vitro diagnostic reagents
  
  and gene treatment centered new anti cancer drugs.
  
  Zhejiang Orient Gene Biotech Co., Ltd. has been listed as hi tech Enterprise of Zhejiang Province, and have obtained in vitro diagnostic reagents production li cense and quality system evaluation certificate conferred by Zhejiang Drug Supervision Bureau.
  
  Some in vitro diagnostic Kits have got registration certificate and have put into sales.
  
  Together with domestic and overseas medical organizations, Zhejiang Orient Gene Biotech Co., Ltd will try its best to promote hi tech diagnostic and treatment technologies to improve medical service level and quality.