CE certification MP rapid test kit/Mycoplasma Pneumoniae rapid test

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  • Min.Order:1000 Piece(s)
  • Production Capacity:20000 pcs/week
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Bioneovan Co.,Ltd

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

8/10

Product Information

Description

   High Sensitivity Mycoplasma Pneumoniae (MP) IgM/IgG                                 rapid test blood group Test                          

Intended Use

 

Rapid mp test card is used to qualitatively detect the existence of MP -IgG antibodies in serum or plasma sample, as an auxiliary diagnostic reagent of MP infection in clinic. Mycoplasma pneumoniae(MP) is the common pathogenic microorganisms that caused the primary atypical pneumonia and other respiratory infections diseases. In addition to the respiratory tract that MP can cause other serious complication. MP infection is widespread and it can cause pharyngitis, tonsillitis, bronchitis, lung abscess, pulmonary bullae and pleurisy and multi system damage. It is not easy to identify the pneumonia is caused by MP, viruses, bacteria and other pathogens infection. And the treatment of MP infection is different to other bacterial or viral infections. After MP infection, MP-IgM appeared first and then decreasing with the climbing and remaining on a high level of MP-IgG titer. In addition, IgM antibody is weak positive generally at the first infection. Therefore, IgM negative do not means inexistence of MP infection. IgG antibody detection is essential and necessary.

 

Principles of the Tests


Rapid mp test card
 is applying the technology of colloidal gold immunochromatography to qualitative test the MP-IgG antibody of serum or plasma samples. The MP-IgG antibodies in positive sample can combine with colloidal gold labeled mouse anti human IgG immobilized on conjugate pad to form immune complex, and move along the membrane strip by chromatography. Some of the complex is caught by recombinant MP Ag pre-coated on T line to form "gold labeled mouse anti human IgG- MP IgG Ab- MP Ag" and develop color. The remaining free complex will be caught by the goat anti-mouse IgG antibody coated on the C line to develop color. As for negative samples, in which have no MP- IgG antibodies, cannot form immune complexes and develop color on the T line, and colorate on C line only.

 

Storage conditions and the period of validity

Store at 4~30°C, dry places for 12 months. Use test card within 1 hour once open to atmosphere when the humidity is below 60%, or use it immediately if the humidity is higher.

 

Test Procedure

 

1.        Test preparation: 10μL, 100μL micropipettes and matched tips

2.        Test process: The temperature of the kit and the test sample should be the same with room temperature before test. Place the test card on a dry horizontal work surface. Add 10μL serum or plasma sample into the sample well, then add 100 μL of sample dilution immediately. Observe the result in 15-20 minutes after the serum or plasma samples added. The observation is invalid after 20 minutes.

 

Packaging & Shipping

 

 

MP rapid test 

 

Rapid test

S/N

Feature

Details

1

Shelf life:

24 months

2

Storage:

Room temperature     

3

Specimen:

Serum

4

Package:

40T/box

5

MOQ:

10box

6

Shipping :

By air

7

Packaging Details:

Express for export

8

Lead Time:

2-3 weeks after the payment

9

Payment Terms:

T/T, Western Union, PayPal or Money Gram

10

Supply Ability:

100,000 kits/Month

11

Place of Origin:

Beijing, China (Mainland)

12

Brand Name:

BIONEOVAN

13

Certification:

ISO13485 & CFDA & GMP

 

 

Our Services

 

1:competitive price with high quality.

 

2: Original manufacturer providOEM service for you.

 

3on time delivery near beijing and tianjin Port.

 

4: Free samples available sent for your evalutaiton

 

5: GMP, ISO9001:2008, SFDA and ISO13485 certificates

 

 

Company Information

 

Bioneovan was built in 1988 in Beijing, China and was the earliest domestic high-tech enterprise which was specialized in the field of ELISA TESTS & RAPID TESTS as both supplier and manufacturer with GMP, ISO9001:2008, and ISO13485 Certificates.

Our products mainly go through the following tests: 
1.Elisa : Hbsag elisa kit, Hbsab, Hbeag, Hbeab, Hbcab, Anti-HCV, HAV igm, HEV Igm, HEV Igg, Anti-HIV1&2, Anti-hiv Ab/Ag elisa test kit and so on.
2. Rapid test : Hbsag cassette hbsag strip, hcv rapid test cassette, hcv rapid test strip, hev igm cassette, hev igg cassette, hav igm cassette, h-pylori ag cassette and other 40 kinds of rapid test cassette or strip.

Basic Information Indicates information has been verified onsite by a certification specialist


Product/Service (We Sell):

Medical Test Kit (elisa Test Kit,  Rapid Test Kit for the Infectious Disease)  


Brands:

Bioneovan


Number of Employees:

101 - 300 People  

Trade & Market


Main Markets:

Southern Europe
Central America
Mid East
Eastern Asia
Northern Europe
Western Europe
South Asia
North America
Southeast Asia
South America
Eastern Europe
Africa
Domestic Market


Total Annual Sales Volume:

US$2 Million - US$5 Million  


Export Percentage:

5% - 15%  

Factory Information


Factory Size (Sq.meters):

5,000-10,000 square meters  


Factory Location:

No.18 Keyuan Road Daxing Industry Zone,Beijing, China No.18 Keyuan Road Daxing Industry Zone,Beijing, China


Number of Production Lines:

2  


Number of R&D Staff:

31 - 40 People  


Number of QC Staff:

11 - 20 People  


Management Certification:

ISO13485   ISO9001,  GMP, FSC 


Contract Manufacturing:

OEM Service Offered  


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