Co-innovation fda ce approved one step hcg pregnancy test strip with 2.5 3.0 3.5 4.0 5.0 6.0 mm different sizes

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Product Overview


Co-innovation fda ce approved one step hcg pregnancy test strip with 2.5 3.0 3.5 4.0 5.0 6.0 mm sizes


                                       in vitro diagnostic rapid test urine test kit supplier


HCG Test Strip Different sizes: 2.5mm/3.0mm/3.5mm/4.0mm/6.0mm


Product Description

Product Description:


Urine Rapid Test Strip Pregnancy Strip Test HCG
Specimen Urine 
Detection Principle Immune colloidal gold
Sensitivity 25mIU/ml (Standard), 20mIU/ml  / 10mIU/ml 
Format: Strip Width:2.5mm, 3.0mm, 3.5mm, 4.0mm, 5mm, 6.0mm
               Cassette 4.0mm
               Midsream 4.0mm, 6.0mm
Accuracy  Over 99.8%
Certificate CE 0123 / FDA K13085 / ISO13485/CLIA-WAIVED
Read time 3-5 minutes
Storage Room temperature 2℃ to 40℃
Shelf life/validity 24-36 months
MOQ 2000 Tests
Customizatioin service OEM LOGO, Private Label, Foil Pouch, Instruction




HCG and LH Product Description:

Co-Innovation 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


Co-Innovation One Step LH Test  Midstream/LH Strip/Cassette is a qualitative test used to predict when there is a LH surge, which is stated to be a reliable way by WHO.

 Intended for over-the-counter (OTC) use
 For in vitro diagnostic use only
Product Details: 
Product name: pregnancy and fertility test strip/cassette/midstream
Format/pattern/shape: strip/cassette/midstream
Width/size: 2.5mm, 3.0mm, 3.5mm, 4.0mm, 5.0mm, 6.0 mm
Specimen: Urine
Time to result: 2- 5 minutes
Sensitivity: 25mLU/ml
Service: OEM Sealed Pouch, Label, Manual, Inner Box etc.
Shelf life/Validity: 24 months 36 months
Certificate: FDA510k, Clia-waived, CE 0123, ISO13485
Package: Single pouch + carton
Advantage: Professional R&D Team with over 10 years experience
Delivery time/Lead time: 
Sample 3-7 days, 10-25 days for bulk order after deposit and package design if needed.
1. Easy to use
2. Easy to read result
3. Accurate as a lab test

4. Results in 5 minutes

5.With CE,ISO13485,FDA510k certificate


How to use:
1. Immerse the strip into the urine
2. Take the strip out after 3 seconds
3.  Lay the strip flat
5.  Read results in 5 minutes.

Company Tour

Factory Pictures:

Co-innovation Biotech specializing in Fertility Hormone Test(One step LH Test and One Step HCG Test), drug of abuse(DOA) test and Infectious Diseases Test.

We believe the world is actually small and flat in the information times. We believe only the best integrity, best human resources and best technology resources can make it possible to provide the most up to date products to customers. If you have the same core value, we are the team for you.

Production Process





How to use HCG



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

2. Remove the test strip from the sealed pouch.

3. Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 5 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.

4. 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.


HCG Test.jpg 


ISO 13485, CE 0123, FDA 510K (K132085), Clia waived


certificates revised




Packaging & Shipping

Packaging & Delivery


Packaging Details:


Mostly OEM Packaging


Format Specimen Sensitivity Kit Details
Strip Urine  25 mIU/ml 100T/Zip Bag, 100zip bags/ CTN
Cassette Urine  25 mIU/ml 100T/Zip Bag, 30zip bags/ CTN
Midstream Urine  25 mIU/ml 100T/Zip Bag, 24zip bags/ CTN



Guangzhou / Shenzhen


Lead Time:

Sample: 3-5 days;

Bulk Order: 10-25 days.


Shipping ways 




Are you manufacturer?
Yes, we are manufacturer locate in Guangzhou, with 100,000 level GMP international standard clean workshop and 10,000 
class clean laboratory,

advanced automated machinery and professional R&D team to ensure the high quality product, fast delivery and large production capacity.

Can we put our logo or text on the products, label, and package?
Yes, we are professional factory do OEM and ODM service. All of our products can be customized.

Are free samples available?
Yes, free samples are available, you only need to pay freight cost, or send to your forwarder.


What is the MOQ?
Small quantity like 1000pcs is acceptable.


How long is your production time?
Sample 3-5 days, bulk order 2-4 weeks after receiving payment or deposit.

How to make the payment?
T/T, L/C, Paypal, Western union and Alibaba trade assurance order are acceptable.

Contact US


                   Contact us



Contact Person: Emily Li

Cel: +86-15920342793

Tel: 020-82109823
Skype: emilylee20091   Wechat/WhatsApp: +86-15920342793
Add: No. 9 Baihe 3 Street, Economic And Technological Development East Zone, Guangzhou 510530, Guangdong P.R. China.

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