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CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic

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CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic

CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic
CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic

Large Image :  CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic

Product Details:
Place of Origin: China
Brand Name: LABNOVATION
Certification: ISO13485,ISO9001
Model Number: LX-401602
Payment & Shipping Terms:
Minimum Order Quantity: 10000 Pieces
Price: Negotiation
Packaging Details: Carton
Delivery Time: 5-7 work day
Payment Terms: T/T, D/A, D/P
Supply Ability: 500000/Day

CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic

Description
Specimen: Saliva Test Time: <15 Min
Group: All People Storage Condition: 2℃-30℃
Quanlity Guarantee Period: 18 Months Freeze: Not Allowed
High Light:

COVID 19 RTK Saliva Self Test Kit

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ISO13485 Saliva Self Test Kit

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CE rtk saliva test kit

Rapid Test Kit COVID-19 Antigen Saliva Rapid Test Kit Self Test 1 Test Single Pack Protable Test Kit


Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in human saliva sample from novel coronavirus suspected person with symptoms within 9 days from onset. The test result can be used for early detection and triage of people suspected of being infected. 

 

Product Details

Item Value
Name SARS-CoV-2 Antigen Saliva Rapid Test Kit (Self Test)
Model Number LX-401602
Type  1 Test
Warranty 18 Months
Power Source Instruction Manual
Quality Certification CE
Safty Standard ISO13485
Sample Type Saliva
Sample volume 3 Full drops
Test Speed Within 15 minutes
Total Accuracy Over 95%

 
CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic 0

Product  Feature

  • Protable and convenient
  • High Accuracy, Sensitivity and Specificity
  • Excellent Performance, Strong test line and control line
  • Easy for use, sample collected is very easy

CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic 1

 
Main Components

  • 1 Test Cassette
  • 1 Saliva Collectors With Collection Tube
  • 1 Sample Extraction Buffer
  • 1 Package Insert

 CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic 2
Sample Collection

  • 30 minutes before sampling, please do not eat, smoke, drinking alcohol or drinks.
  • Place the tip of tongue against the upper or lower tooth root to enrich saliva, and then swallow saliva to the throat without ingesting saliva to esophagus, followed by returning saliva to the mouth. Repeat the process for 5 times.

Use Step

  • Open the cap of the collection tube and istall saliva collector.
  • Put the collection tube with saliva collector close to lips and let the saliva flow into the collection tube. Tje volum of saliva needs to be half of 0.5 scal mark(0.25).
  • Screw the sample extraction buffer carefully.

CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic 3

  • Add all sample extration buffer to the collection tube. Discard the saliva collector, tighten the cap onto the specimen collection tube.
  • Shake the specimen collection tube at least three time vigorously to mix the saliva and the extraction buffer. Squeeze bottom of the collection tube ensure the saliva is thoroughly mixed.
  • Add 3 full drops of the solution to the sample well(S). Read the result at 15 minutes. Do not interpret the result after 20 minutes.

 CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic 4
Result Interpretation

  • POSITIVE: Two (2) distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).

  • NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in the test region (T). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit.

  • INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

 

 CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic 5
Virus Sources

Global high frequency mutation Alpha / B.1.1.7(U.K.) Beta I B.1.351(South Africa)
Gemma I P.1(Brazil) Kappa I B.1.617.1(India) Delta I B.1.617.2(India)
C.37,ect Alpha I B.1.17(U.K.) B.1.36.16.etc
A.2.5,etc A.23.1 Alpha I B.1.17(U.K.)
B.1.1.33.etc C.1.1.etc. etc.

Storage And Expiry

Store as packaged in the sealed pouch at 2-30℃, avoid heat and sunshine, dry place, valid for 24 months. Do not freeze. Do not open the inner packaging until ready, it must be used within one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity>60%.
Precaution

  • For IN VITRO diagnostic use only.
  • Waste should be treated in accordance with infectious substances and should be discarded properly.
  • The extraction reagent contains preservative agent which may be toxic if ingested. When disposed of through a sink, flush with a large volume of water.
  • Do not use samples that have been placed for longer than one hour or contaminated.
  • If the saliva is not well mixed in the sample extraction tube, false negative results may occur.

FAQ

  • Production quantity?

It depends on the specification of the products. For big orders, we can produce 100k-250k per day.

  • Have after-sale service?

Yes we support technical services. And if the goods are missing due to our fault, we promise to compensate.

  • Register your products in our country?

Yes. We can offer full files for you to register.

  • Lead time?

Stock 3-7 days in general. Or please contact us by email for specific lead time base on your order quantities.

 

  • Support ODM or OEM?

Yes we support both. If needed,welcome to discuss details with us.

Contact Details
Labnovation Technologies, Inc.

Contact Person: Ld

Tel: +8613480985156

Send your inquiry directly to us (0 / 3000)