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Ketamine KET Cassette Rapid Test Kit FDA Certificate

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO, CE, FDA
Model Number: KET-DU2
Minimum Order Quantity: 5000 units
Price: Negotiable
Packaging Details: 25test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Detail Information
Sample: Urine Certificate: ISO, CE, FDA
Type: Cassette Shelf Life: 24 Months
Usage: Professional Use Origin: China
High Light:

Ketamine Rapid Test Kit

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FDA Certificate Rapid Test Kit

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KET Cassette Rapid Test


Product Description

Ketamine(KET)Rapid Test

 

Ketamine(KET)Rapid Test is a rapid, screening test for the qualitative detection of Ketamine(KET)and metabolites in human urine at specified cut off levels.

For professional use only.

For in vitro diagnostic use only.

 

【INTENDED USE】

Ketamine(KET)Rapid Test is an immuno-chromatographic assay for the qualitative determination of the presence of Ketamine(KET) listed in the table below.

Drug(Identifier)

Calibrator

Cut-off level

Ketamine(KET)

Ketamine

250 ng/mL

 

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to Ketamine(KET)) of abuse test result, particularly when preliminary positive results are indicated.

 

SUMMARY

Ketamine is a dissociative anesthetic developed in 1963 to replace PCP (Phencyclidine). While Ketamine is still used in human anesthesia and veterinary medicine, it is becoming increasingly abused as a street drug. Ketamine is molecularly similar to PCP and thus creates similar effects including numbness, loss of coordination, sense of invulnerability, muscle rigidity, aggressive / violent behavior, slurred or blocked speech, exaggerated sense of strength, and a blank stare. There is depression of respiratory function but not of the central nervous system, and cardiovascular function is maintained.The effects of Ketamine generally last 4-6 hours following use. Ketamine is excreted in the urine as unchanged drug (2.3%) and metabolites (96.8%).

 

PRINCIPLE

Ketamine(KET)Rapid Test is a competitive immunoassay that is used to screen for the presence of Ketamine(KET)and metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.

 

When the test is activated, the urine is absorbed into test Cassette by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test Cassette. This produces a colored Test line in the Test Region (T) of the Cassette, which, regardless of its intensity, indicates a negative test result.

 

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

 

To serve as a procedure control, a colored line will appear at the Control Region (C) of Cassette, if the test has been performed properly.

 

【WARNINGS AND PRECAUTIONS】

  • Immunoassay for in vitro diagnostic use only.
  • Do not use after expiration date.
  • The test should remain in the sealed pouch until use.
  • The used test should be discarded according to local regulations.

 

【CONTENTS】

  • Drug Test.
  • Desiccant
  • Leaflet with instruction for use.

 

【STORAGE AND STABILITY】

  • The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
  • The test must remain in the sealed pouch until use.
  • Keep away from direct sunlight, moisture and heat.
  • Do not freeze.
  • Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

 

【OPERATION】

Test must be in room temperature (15ºC to 30ºC)

  1. Donor collects urine specimen in a urine cup.
  2. Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.
  3. Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.
  4. The result should be read at 5 minutes. Do not interpret the result after 10 minutes. See the illustration below.

 

 

【INTERPRETATION OF RESULTS】

Preliminary positive (+)

Only one colored band appears, in the control region (C). No colored band appears in the test region (T).

Negative (-)

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

Invalid

Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

 

 

 

 

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +008615267039708