FDA 510K Approved- Customized Drug and Alcohol Screening Solutions

Product Details
Type: Urine/Hematology Analyzer
Material: Plastic
Quality Guarantee Period: Two Years
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Number of Employees
110
Year of Establishment
2012-03-29
  • FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
  • FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
  • FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
  • FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
  • FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
  • FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
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Basic Info.

Model NO.
8 10 12 14 16 panel drug test cup
Group
Adult
Logo Printing
OEM
Product Name
Drugs of Abuse Testing Drug Test
Feature
Drug Test Kit 10 12 Panels
Usage
Urine Drug Test Cup
Format
Cup/Cassette/Strip/Dipcard
Application
Self-Testing, Professional Testing
Name
Drugs of Abuse Tests Cup
Series
Medical Devices Equipment
Packing
Individual Foil Pouch, Inner Box
Certificate
ISO13485/ FDA/ Clia-Waived
Function
Laboratory Drug Testing
Medical Device
Pre-Employment Drug Testing
Types
Multi Drug Screen Test
Sensitivity
High Accuracy 99.99%
Applications
Home/ Hosipital/ Clinic/ Workplace Testing
Specifications
OTC Diagnostic
Transport Package
Valve Bag/Box, Carton
Specification
25 tests/ inner box, 100 test /carton
Trademark
CIBIO
Origin
Guangdong, China
HS Code
3822001000
Production Capacity
1000000PCS/Week

Product Description

 FDA 510K Approved- customized drug and alcohol screening solutions

 DOA drug of abuse test format: Strip, Cassette, Dipcard, Cups

 

DOA Introduction

Single and Multi Panel Drug Test DOA Drug Test Strip/ Cassette/ Cup

 

Co-Innovation One Step Drug Test is a competitive immunoassay using screen for the

 presence of various drugs and drug metabolites in urine. 

It is chromatographic absorbent device. During testing, a urine specimen migrates upward by capillary action. A certain drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. 

 

Same As A Standard Lab Test Multi Drug-Test for THC, Cocaine (COT), Methamphetamine(MET), Amphetamines(AMP), Opiates(OPI),  and Benzodiazepine(BZO), Ethyl Glucuronide(ETG), Fentanyl(FYL) etc.

Simple And Easy To Use - Convenient Medical Drug Test Devices and Home Drug Testing! More than 99% accurate in detecting specific drugs according to the designated cut-off level.

Product Shows:FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
FDA 510K Approved- Customized Drug and Alcohol Screening Solutions


Product Overviews:
 

Product Name
 
Cut-off level(ng/mL)

Rapid Amphetamine (AMP)
 
1000ng/ml

Rapid Barbiturates (BAR)
 
300ng/ml

Rapid Benzodiazepines (BZO)
 
300ng/ml

Rapid Buprenorphine (BUP)
 
10ng/ml

Rapid Cocaine (COC)
 
300ng/ml

Rapid THC
 
50ng/ml

Rapid Methamphetamine (MET)
 
1000ng/ml

Rapid Methadone (MTD)
 
300ng/ml

Rapid Methadone Metabolite (EDDP)
 
300ng/ml

Rapid Ecstasy (MDMA)
 
500ng/ml

Rapid Opiate 2000 (OPI)
 
2000ng/ml

Rapid Oxycodone (OXY)
 
100ng/ml

Rapid Phencyclidine (PCP)
 
25ng/ml

Rapid Propoxyphene (PPX)
 
300ng/ml

Rapid Tri-cyclic Antidepressants (TCA) Test
 
1000ng/ml

Rapid Cotinine (COT)
 
200ng/ml

Rapid Ethyl Glucuronide (ETG)

500ng/ml
Rapid Fentanyl (FYL)

200ng/ml


Synthetic K2
 
50ng/ml

6-Monoacetylmorphine (MAM)
 
10ng/ml

 

FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
FDA 510K Approved- Customized Drug and Alcohol Screening Solutions

Product Description:

Co-Innovation Rapid Multi-drug Test strip/dip card/cup is simple to administer, all-inclusive drug screen. With up to 21 drug assays( THC, AMP, BAR, BZO, COC, MET, MOP, MTD, OXY, PCP, BUP, MDMA, TCA, K2, FYL, TRA, 6-MAM)  and multiple configurations in one cup/dip card and result that can be photocopied.

 

Product Details:

Product name:  Rapid Multi-drug Test  (Drug of Abuse test )               

Format/pattern/shape: Strip/Dip card/Cup

 

Specimen: Urine

Time to result: 2- 5 minutes            

Service: OEM Sealed Pouch, Label, Manual, Inner Box etc.

Shelf life/ validity: 24 months            

Certificate: CE 0123, ISO13458, FDA 510k, CLIA-WAIVED

Storage: between4-30°C                                            

Accuracy: Over 99.5%                         

Package: single pouch + carton 

Advantage: Professional R&D Team over 10 years.

 

Delivery time/Lead time:

3-7 days for sample order

10-25 days for bulk order after deposit and package design if needed.

 

Advantage:

1. Easy to use
2. Easy to read result
3. Accurate lab test
4. Results in 5 minutes


Characteristic:

1. Lid tighten indicator design.

2. Minimum fill volume only 20ml.

3. Results stable up to 30 minutes.

4. 2 to 25 drug configurations, easy combo kits.

5. 24 months shelf life.
 

 

How to test:
FDA 510K Approved- Customized Drug and Alcohol Screening Solutions
 


Custom drug testing Formats:

Single Test Strip,Single and multi-drug dipcard,  Urine multi-drug screen cup:


FDA 510K Approved- Customized Drug and Alcohol Screening Solutions


Certificates:

ISO 13485, US FDA 510K, CLIA-Waived, CE

FDA 510K Approved- Customized Drug and Alcohol Screening Solutions



 


Shipping way and packaging:

FDA 510K Approved- Customized Drug and Alcohol Screening Solutions

 


 Factory Tour:

Co-Innovation Biotech Co.,Ltd.

Co-Innovation Biotech Co (CIBIO®) was founded in 2012 in Guangzhou, China. We specialize in R&D, manufacturing, and marketing of rapid in vitro diagnostic tests and detection readers. We offer extensive products including lateral flow immunoassays for fertility( pregancy and ovulation test), drugs of abuse, infection, and tumor markers.

Co-Innovation Biotech is an ISO certified manufacturer. Our products are 510(k) cleared, CLIA waived, CE and OTC. We provide large scale OEM and CMO services to various organizations and retail business around the world.

Co-Innovation Biotech is a leader in the research, design, production, and supply of advanced in vitro diagnostic test products for professional use and home use. We are committed to advancing personal health and well-being and delivering the needs of our consumers through a continuing flow of new and inventive developments. Our mission is to construct first-class products while providing outstanding customer service. We want to accomplish this while enjoying life and maintaining exceptional health. 


FDA 510K Approved- Customized Drug and Alcohol Screening Solutions


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FDA 510K Approved- Customized Drug and Alcohol Screening Solutions



 

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