Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra

Product Details
Classification: Biological Diagnostics
Type: Urine Analyzer
Certification: CE, FDA, ISO13485, FSC / Cfs
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Number of Employees
110
Year of Establishment
2012-03-29
  • Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra
  • Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra
  • Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra
  • Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra
  • Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra
  • Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra
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Basic Info.

Group
Female
Format
Strip, Cassete, Midstream
Usage
It Is Intended for Over-The-Counter (OTC) Use.
Function
Detects HCG/Lh in Urine
Service
OEM / ODM Service
Sensitivity
10 Miu/Ml ; 20 Miu/Ml ; 25 Miu/Ml
Accuracy
Over 99 %
Transport Package
Cartons
Trademark
Cibio test
Origin
China
HS Code
3822190090
Production Capacity
500, 000 PCS/ Day

Product Description

Product Description

One Step HCG Test Strip/Cassette/Midstream 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 intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

 

Product Specification

One Step HCG Pregnancy Test : Strip/Cassette/Midstream
Name Pregnancy Test Kit
Format A. Strip
B. Cassette
C. Midstream
Specimen Urine
Sensitivity (mIU/ml) 10 mIU/ml ; 20 mIU/ml ; 25 mIU/ml
Size(mm) A.Strip:2.5mm, 3.0mm, 3.5mm, 4.0mm,5.0mm, 6.0mm
B.Cassette: 4.0 mm
C.Midstream:4.0mm, 6.0mm
Packing, OEM service are also accepted A. Strip:1 test/ pouch, 10000 tests / carton
B. Cassette:1 test/ pouch, 3000 tests / carton
C. Midstream: 1 test/ pouch, 2400 tests / carton
Accuracy  > 99 %
Certificate FDA 510K, CE 0123, ISO13485, FSC/CFS
Lead time Samples: 3-7 days  ;
bulk order :10-25 days after deposit and confirmation of OEM package design if needed.
Loading Port Guangzhou / Shenzhen
Our Main Products: Pregnancy & Fertility test, Drugs of Abuse test


Time to result: 3- 5 minutes
Service: OEM Sealed Pouch, Label, Manual, Inner Box etc.
Shelf life/Validity: 24-36 months
Package: Single Pouch + Inner Zip bag / Inner  box + Outer Carton 
Advantage: Professional R&D Team with over 10 years experience

 
Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K MhraHuman Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra
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.


Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra

Certifications:

Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra

More Products:

Human Chorionic Gonadotropin Pregnancy Test Kit CE FDA 510K Mhra


FAQ

1: You are manufacturer or a trading company ?

CIBIO is a professional manufacturer specializing in manufacturing Prenancy and Fertility Test , Drug of Abuse(Single Test and Multi Test). We enjoy great reputation among our customers not only for competitive price, qualified product but also for excellent service.

2: How to get samples ?

It is our great honor to offer you samples for free, but new clients are expected to pay the shipping cost.
Can also be collected by customers' Fedex,UPS,DHL,etc. account.

3: Do you offer OEM or ODM Service ?

Yes, OEM or ODM services available. All of our products can be customized.

4: How does your factory do regarding quality control ?

Quality is Life! So we always focus on quality controlling during the whole process.

1)  We have FDA, CE, ISO13485 certification, so far all the production process, we have standard rules;

2)  We have QC team, we have third times QC before shipping out cargo.

3)  We do observe the relevant for conduct & laws form government in environment, human rights and aspects like no children labor, no prisoner labor and so on.

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