FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip

Product Details
Sensitivity: 10 Miu/Ml, 20 Miu/Ml, 25 Miu/Ml
Strip Size: 2.5, 3.0, 3.5, 4.0, 5.0, 6.0 mm
Shelf Time: 24-36 Months
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Number of Employees
110
Year of Establishment
2012-03-29
  • FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip
  • FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip
  • FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip
  • FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip
  • FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip
  • FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip
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Basic Info.

Model NO.
C101S1
Result Time
3-5 Minutes
Packaging Service
OEM / ODM Service Avalilable
Classification
Biological Diagnostics
Type
Urine Analyzer
Certification
CE, FDA, ISO13485, Fsc / Cfs
Group
Female
Transport Package
Normally Bulk Pack; OEM Packaging Available
Specification
58.5*37.3*44cm
Origin
China
HS Code
3822190090
Production Capacity
500, 000 PCS/ Day

Product Description

Product Description

One Step HCG Test Strip is an in vitro diagnostic home use test device intended for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. You can easily carry out yourself.
It is intend for over-the-counter (OTC) use.
For in vitro diagnostic use only.

FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip


Human chorionic gonadotropin (HCG) is a hormone, produced by the developing placenta and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone.

When the sample end of the test is dipped in the urine specimen, the urine specimen is applied to the strip and migrates along the strip. 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.


A colored line will appear at the Control Zone region if the test has been performed properly.

Product Characteristic
 
Product Names HCG Pregnancy Test Strip
Width Size of Strip 2.5, 3.0, 3.5, 4.0, 5.0, 6.0 mm
Sensitivity 10mIu/ml , 20mIu/ml , 25mIu/ml
Specimen Urine
Accuracy ≥ 99%
Read time 3-5 Minutes
Shelf Validity  24-36 Months
Storage  4ºC to 30ºC
Certificates ISO13485,  CE,  FDA 510K, FSC
Minimum Order Quantity 10000 pcs ( 1 carton )

Product  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

How to do the Test ?

1. Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 3  seconds and lay the strip flat on a clean, dry, non-absorbent surface (such as the mouth of the urine container). 
IMPORTANT: Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.

2. The test strip and urine have to be at room temperature 59-86ºF (15-30°C) for testing.

3. Read results in five minutes. Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result. 
Do not read results after more than 5 minutes.



Company Profile:

Co-Innovation is an innovative and creative enterprise in R&D, manufacturing and marketing of rapid diagnostics tests. 

In 2012, Co-innovation was established in Guangzhou, China. Specialized in lateral flow immunoassay technology, we provide diagnostics tests to global market with pregnancy tests, ovulation predictor, drug of abuse tests.

Our products are being sold to many countries, including United States, Germany, Netherlands, England, Chile, Ecuador, Malaysia, Singapore, India, Australia etc.

Our products have been widely recognized and enormously supported, we aim to produce high cost-effective products, and create the greatest value for customers.


FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip





Certifications:

FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip

More Products:

FDA 510K One Step Urine Rapid HCG Pregnancy Test Strip

Contact US

Contac Person: Shirley Pang
 
Add: No. 9 Baihe 3 Street, Economic And Technological Development East Zone, Guangzhou 510530, Guangdong P.R. China.

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