Rapid HCG Pregnancy Test Strip Cassette Midstream FDA510K CE0123 ISO13485

• Classification: Biological Diagnostics
• Type: Urine Analyzer
• Certification: CE, FDA, ISO13485
• Model NO.: C101S1-C101S6, C101C1, C101M1-C101M2
• Group: Female
• Product Name: Rapid HCG Pregnancy Test Kits
• Specimen: Urine
• Format: Strip, Cassette, Midstream
• Sizes: Strip: 3.0mm, 3.5mm, 4.0mm ; Cassette & DIP: 4.0mm
• Sensititive: 10 Miu/Ml ; 20 Miu/Ml ; 25 Miu/Ml
• Shelf Time: 36 Months ( 3 Years )
• Accuracy: Over 99%
• Storage: 4c -30c
• Time to Result: Within 5minutes
• Certificates: FDA 510K, CE0123, ISO13485, Mhra
• Usage: in Vitro Diagnostic
• Funtion: Professional Testing, Self-Testing
• Service: OEM / ODM Service
• Advantage: Easy to Read and Use, Fast and Clear Result
• Delivery Time: Samples: 7-15 Days, Formal Order: 25-30days
• Transport Package: 1PC/Pouch, 100PCS/Bag, 2400PCS/CTN
• Specification: Strip: 100 tests/box, 10000pcs/carton
• Trademark: Co-Innovation
• Origin: Guangzhou
• HS Code: 3822190090
• Production Capacity: 500, 000PCS/Day

Product Description

Rapid HCG Pregnancy Test Kits

Product details:

Name	HCG Pregnancy Test Strip/Midsream/Cassette
Specimen	Urine
Detection Principle	Immune colloidal gold
Sensitivity	25mIU/ml
Format: Strip	Width:2.5-6.0mm for choice
cassette	4.0mm
Midsream	4.0mm,6.0MM
Accuracy	Over 99.8%
Certificate	CE/FDA K13085 /ISO13485
Read time	3-5 min
Storage	Room temperature 2ºC to 40ºC
Shelf life/validity	24 months
MOQ for normal      package	2000Tests
Other service	OEM service available

 

Characteristics:

1. Early detection of pregnancy as early as 7 days after the fertilized egg implantation

2. Simple to use

3. A variety of design specifications suitable for self-testing use and for professional use

4. Results in 2 to 5 minutes

5. Store in room temperature between4 to 30°C, do keep away from direct sunlight, moisture and heat

HCG test  kit Format available:

Strip,Cassette,Midstream for choice:

 

 

How to test:

 

 Ceritificates:

  ISO 13485,FDA510K,CE0123

Shipping way:

CO-Innovation profile:

At CIBIO we believe that people from every corner of the world want to be involved in their own healthcare with ease to use medical products and every healthcare worker like to give a quick and accurate solution to release their patients pains and worries. When they do so, they have more confidence to improve quality of life and quality of work. We are proud that we are part of this great contribution to improve people's life. 

At CIBIO we believe the world is actually small and flat in the information times. We are not developing a better technology alone. There are millions of talents and intelligence, organizations are working on innovative technology and better products. We believe only the best integrity of the world best human resources and best technology resources can make it possible to provide the most up to dated products to customers.  So we will continuously dedicated to build up an open Co-innovation platform which is strategically planned and developed.