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Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485

China Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485, Find details about China Pregnancy Test Kit, Pregnancy Test from Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485

Model NO.
HCG-S
Methodology
Colloidal Gold Immune Chromatographic Assay
Specimen
Urine
Format
Strip /Cassette /Midstream
Sensitivity
10miu/Ml or 25miu/Ml
Accuracy
More Than 99%
Reading Time
3-5mins
Certification
CE, ISO13485, FSC, Cfda
Service Support
OEM/ODM
Trademark
GOLDEN TIME, OEM/ODM
Transport Package
1/2/5/25/50/100PCS/Box
Specification
2.5mm/3.0mm/4.0mm/5.0mm/5.5mm/6.0mm
Origin
Hebei Province, P. R. China
HS Code
3002150090
Model NO.
HCG-S
Methodology
Colloidal Gold Immune Chromatographic Assay
Specimen
Urine
Format
Strip /Cassette /Midstream
Sensitivity
10miu/Ml or 25miu/Ml
Accuracy
More Than 99%
Reading Time
3-5mins
Certification
CE, ISO13485, FSC, Cfda
Service Support
OEM/ODM
Trademark
GOLDEN TIME, OEM/ODM
Transport Package
1/2/5/25/50/100PCS/Box
Specification
2.5mm/3.0mm/4.0mm/5.0mm/5.5mm/6.0mm
Origin
Hebei Province, P. R. China
HS Code
3002150090
   One Step HCG Pregnancy Test Kit

INTENDED USE

It is designed for qualitative determination of HCG in urine doe early detection of pregnancy.

FEATURES AND BENEFITS

• easy to use in one simple step
• Fast results in 5 minutes
• 99.96% accuracy

DIRECTIONS FOR USE

• Step 1: remove the test strip from the foil pouch.

• Step 2: immerse the strip into the urine with the arrow end pointing toward the urine. Do not cover the urine over the MAX(maximum) line.

You may take the strip out after a minimum of 15 seconds in the urine and lay the strip flatly on a non-absorptive clean surface.

• Step 3: read the results within 5 minutes. Do not interpret result after 5 minutes.

PACKAGING DETAAILS

In bulk
1pcs per box
2pcs per box
50pcs per box
100pcs per box

STORAGE CONDITION

Shelf-life: 3 years from manufacturing date.
Store at 4°C~30°C. It should avoid light, moisture and cryopreservation.
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
 
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
 
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
 Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
 

Product name

One Step HCG Pregnancy Test

Brand Name

GOLDEN TIME

Methodology

Colloidal gold immune chromatographic assay

Specimen

Urine

Format

Strip /Cassette /Midstream

 

Size

Strip: 2.5mm/3mm/4mm/5mm

Cassette :3mm/4mm

Midstream:3mm/5mm/5.5mm/6mm/7mm

 

Specification

Strip: 1/2/5/25/50/100pcs/box

Cassette :1/2/5/25/50/100pcs/box

Midstream:1/2/5/25/50/100pcs/box

Sensitivity

10mIU/ml or 25mIU/ml

Accuracy More than 99%

Specificity

No across reactivity with 500mIU/ml of hLH, 1000mIU/ml of hFSH and 1mIU/ml of hTSH

Reading time

3-5mins

Place of origin

Hebei province, P.R. China

Certification

CE, ISO13485, FSC, CFDA

Service support

OEM/ODM
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
                  PRISES Biotechnology, is a R&D based manufacturer, engaged in development, manufacturing and trading of in vitro Diagnostic Reagents (IVD) and Medical Equipment, which approved for manufacturing and trading IVD products from NMPA(CFDA) and operated under quality system of ISO 13485, most of products have been certified with CE mark.

Our factory is founded in 2012 and located in Gaobeidian City, which is near Xiongan New Area and Beijing. It covers an area of 3,000 square meters, including class 1000,000 clean workshop with 700 square meters, class 10 thousands of microbiological testing room with 200 square meters, well-equipped quality inspection rooms, research and development laboratories, etc.

PRISES Biotechnology is producing highly sensitive urine Fertility tests, such as pregnancy test, ovulation test or FSH tests for professional use and self-testing under brand name of Golden Time, as well as OEM/ ODM basis. It is also providing an extensive range of Immunochromatography based one-step rapid tests for infectious diseases & Respiratory diseases for HBsAg, Anti-HBs, HCV, HIV 1/2, Syphilis, Malaria P.f/P.v, Dengue IgG/IgM, Dengue NS1, H.Pylori, 19 Antigen test, 19 Antibody test, 19 Neutralizing Antibody test, and other unique rapid tests, mask, Disposable Virus Sample Tube, Condoms, etc.

Our products are sold well in China market, they are also exported to clients in such countries as Poland, United Kingdom, Germany, Portugal, France, Bulgaria, Turkey, Ireland, Egypt, South Africa, Madagascar, South Korea, Peru etc. Adhering to the business principle of mutual benefits, we have had a reliable reputation among our customers because of our professional services, quality products and competitive prices. We are glad to work with you for common success and bring you the satisfied products.
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485
Q1: How can i distinguish a good test kit ?
A1: U can judge from the 4 facts:
Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.
Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.

Q2:Can I have a sample for our testing?
A2: Yes, free samples are available by freight collected. And we will return the freight in the first order. 

Q3:What is sample ready time?
A3: Usually 1-7 days, since it was produced against specific demands to guarantee most freshness.

Q4:What about the order payment methods and delivery time?
A4: 1) 30~70% T/T advance, balance before delivery, Irrevocable L/C at sight.
Delivery time usually 1-45 days after receiving the deposit. Our brand package takes 15 days, OEM package takes around 35 days.(Due to factors such as the power limit of the factory and the surge in demand for test kits, in order to ensure the delivery date, we have reserved several production lines to ensure the normal production of conventional kits and both regular customer orders and new orders will not be affected.)

Q5:Can I print our logo on the package?
A5: Yes, as a manufacturer, we can according to your requirements, the size of the product, the appearance of the design of the program, colleagues can sample order,official authorization will be required. We do not accept orders for imitation brand. We do not do business that harm other brands and companies, as were victims once.

Q6. Will you help me register the products in my country ?
A6: Sure, we will provide all you documents and samples you need for register, but express cost will be paid by your company.

Q7:How to deal with the products regarding the quality and quantity?
A7: PRISES Biotechnology is a professional supplier for the medical products for many years. It is of great importance for the quality issues, QC department will arrange the checking every lot, also we have the spot checking at random, we keep high concentration of quality issues, also quantity issues , which is the life of a company, we carry out all our technique skills according to CE mark , FSC , EU declaration conformity, ISO 13485 and so on .

Q8:Can i have a phone call directly with your sales if some urgent questions?
A8: Yes, of course, that is wonderful to save the time and catch the key point easily.  If you have any questions, you can call us or send us by email. 
Early Rapid Urine HCG Pregnancy Test Kit with CE ISO13485

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