New Pharmaceutical Chemical Regent Antigen Rapid Test (CCV AG) Kit

• Type：Surgical Supplies Materials
• Material：Plastic
• Ethylene Oxide Sterilization：Ethylene Oxide Sterilization
• Quality Guarantee Period：Two Years
• Group：Adult

=== Base Info ===

• HS Code：3002150090

=== Description ===

Basic Info.

HS Code 3002150090

Product Description

For-master Igg/Igm Rapid Test Kit
  

Product Description

New Virus IgG/IgM Rapid Test Device is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG New virus and IgM New virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with New viruses. Any reactive specimen with New Virus IgG/IgM Rapid Test Device must be confirmed with alternative testing method(s).

 

Test Procedure &Inter pretation





MATERIALS SUPPLIED
40 sealed pouches each containing a test cassette, a dropper and a desiccant
Buffer
1 package insert
40 In pursuance of the needle (for fingerstick whole blood only)
MATERIAL REQUIRED BUT NOT PROVIDED
1. Centrifuge (for plasma only)                  
2. Timer
3. Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning.

Features & Benefits
• Fast results as soon as 1-15 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• Little specimens, only 10 μL of serum/plasma or 10 μL of whole blood specimens
• All necessary reagents provided & no equipment needed
• High sensitivity and specificity
Product Comparison

Company Information

Established in Feb.2019, Anhui Formaster Biosci Co., Ltd. is located in Anhui Wuwei Economic Development Zone. The site area is 1,500 sq. meters with a clean room of 300 sq. meters. The company is specialized in researching, developing and manufacturing in vitro diagnostic (IVD) devices with advanced technology, high R&D input and innovation. Granted certification, the leading products are rapid diagnostic devices, focusing on the following 7 categories,  antibody, women's health, infectious diseases, drugs, cancer, cardiovascular and respiratory. Our professional team is the national leader in colloidal gold, latex and other labelling technologies, biological raw materials technologies, including monoclonal antibodies, polyclonal antibodies, genetic recombinant antigens, synthetic antigen, etc., as well as other cutting-edge biological fields, such as immunochromatography.
 
Our company is registered in MHRA, UK and listed in Medical Devices and Supplies Companies with Certification/Authorization from other Countries (CCCMHPIE, China) for exporting our Novel  IgM/IgG Antibody Combo Test Kit (Colloidal Gold).


Certifications





Factory Site









 

My Service 

1: Factory direct price. Price is competitive with high quality.
2: Original manufacturer provide OEM & ODM services for you. OEM Service including private labeling, color box and pouch printing & customized assembly are available.
3: Smooth delivery near Shanghai and Ningbo Port.
4. FOB, CIF, DDU services/prices for you to choose.
 

FAQ 

 1. Q: Can I get a sample before bulk order? How can I get it?         
     A: Reasonable quantity samples available to be sent for your evaluation, we can send samples to you by Express(UPS or FedEx). You could prepay the sample cost & freight cost via PayPal/Western union, we will send out sample as soon as I can once getting your payment.
  2. Q: Do you have minimum order requirements?
       A: No, according to client's need.
  3. Q: Can we visit your factory?
      A: Certainly. Welcome your visit.
  4. Q: How to ensure the cargo quality?
      A: A professional QC team will control the goods quality during all the mass production or a third party inspection service could be arranged at your expense if you want. We will supply bulk sample for evaluation before shipping.
 5. Q: What's the payment method?
     A:  You can pay USD, EURO & RMB via T/T, PayPal or Western Union.
 6. Q: Which certificates do you have?
     A: CE, ISO13485 certificates.SGS
 7. Q: Why choose FM?
     A: We are the professional China rapid test supplier/manufacturer/factory for wholesale rapid test not trading company, so the price is quite competitive in the market.


FM Medical Products Advantage

Excellent Precise, One-step Rapid, High Sensitive, high quality but not expensive(at a range of prices) with long shelf life.


For more tiered pricing based on different order quantity and customized requirements, please do not hesitate to contact us, we are all looking forward to hearing from you very soon.