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Professional Drug Test Cup Medical Diagnostic Kit FDA 510K Approval

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Professional Drug Test Cup Medical Diagnostic Kit FDA 510K Approval

China Professional Drug Test Cup Medical Diagnostic Kit FDA 510K Approval supplier

Large Image :  Professional Drug Test Cup Medical Diagnostic Kit FDA 510K Approval

Product Details:

Place of Origin: CHINA
Brand Name: Neutral packing / OEM
Certification: CE,FDA 510K, FSC
Model Number: CT-D-01/02/03/04

Payment & Shipping Terms:

Minimum Order Quantity: 2000pcs
Price: USD
Packaging Details: individual sealed pouch, 25pcs/case, 4 cases/ carton box
Delivery Time: Depending on order QTY
Payment Terms: T/T,Paypal
Supply Ability: 100,000pcs/Month
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Detailed Product Description
Parameter: THC, MET,COC,BUP,BZO,AMP,etc Qualified: CE,FDA 510k, CLEARED, CLIA WAVIED
Specimen: Urine Shelf Life: 24months
Feature: High Sensitivily Name: Urine Test Kit

Integrated Split Cup of Multi Drug Abuse Testing with Key to Control Test

 

Direction for use

 

 

SPECIMEN COLLECTION AND PREPARATION

 

WHEN TO COLLECT URINE FOR THE TEST?

The minimum detection time is 2-7 hours, so you may collect urine samples 2-7 hours after suspected drug use.

 

HOW TO COLLECT URINE?

1. Urinate directly into the provided urine cup.

2. Open the Labeled Vial and carefully pour the urine specimens from the urine cup into the Labeled Vial. Fill the vial to about two thirds (2/3) full and tightly close the cap. This Labeled Vial urine sample is for shipping to the laboratory for confirmation testing. Make sure that the number on the Labeled Vial matches your personal Identification Number.

3. The residual urine sample in the urine cup is for your self-testing.

 

Specimen Storage

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.

 

Note: Allow the test cup to come to room temperature [15-30℃ (59-86℉)] prior to test.

 

1. Bring the pouch to room temperature before opening it. Remove the cup from the sealed pouch and use it as soon as possible.

2. Remove the key by twisting it from the center of the cup cap.

3. Collect specimen in the cup and secure cap tightly by pressing down on the pull tab until an audible click is heard.

4. Technician dates and initials the security seal and attaches the security seal over the cup cap.

5. Place the cup on a flat surface and push the key to a fully closed position to initiate the test. Start the timer.

6. Remove the peel off label covering the test results.

7. If adulteration is included on the test cup, read the adulteration strip(s) between 3 and 5 minutes. Compare the colors on the adulteration strip to the enclosed color chart. If the specimen indicates adulteration, refer to your Drug Free Policy for

guidelines on adulterated specimens. We recommend not to interpret the drug test results and either retest the urine or collect another specimen.

8. Read the drug strip results at 5 minutes. The drug test results remain stable for up to ONE HOUR.

 

Test Calibrator Cut-off (ng/mL)
Methamphetamine (MET, mAMP ) D-Methamphetamine 1,000
Methamphetamine (MET, mAMP ) D-Methamphetamine 500
Cocaine(COC ) Benzoylecgonine 300
Cocaine(COC ) Benzoylecgonine 150
Marijuana (THC ) 11-nor-Δ9-THC-9 COOH 50
Morphine (MOP ) Morphine 2,000
Morphine (MOP ) Morphine 300
Benzodiazepines (BZO) Oxazepam 300
MDMA(Ecstasy) D,L- Methylenedioxy-methamphetamine 500
Oxycodone (OXY ) Oxycodone 100
Barbiturates (BAR) Secobarbital 300
Buprenorphine (BUP) Buprenorphine 10
Methadone (MTD) Methadone 300
Phencyclidine (PCP) Phencyclidine 25
Amphetamine (AMP) D-Amphetamine 1,000
Amphetamine (AMP) D-Amphetamine 500
EDDP (Methadone Metabolites) 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP) 300
Tricyclic Antidepressants (TCA) Nortriptyline 1,000
Propoxyphene (PPX) Propoxyphene 300
 

 

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

 

 

Insert

 

DOA Cup  with Key Insert.pdf

 

Contact Details
Care Test Biotech Ltd

Contact Person: lilywong

Tel: +8617338314955

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