AllSource Screening Solutions - Drug Detector - ALLSOURCE SCREENING SOLUTIONS, LLC

Duns Number:080358180

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More Product Details

Catalog Number

-

Brand Name

AllSource Screening Solutions - Drug Detector

Version/Model Number

ALL6125R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Device Record Status

Public Device Record Key

d2b8fc1a-fcd5-48a4-9b62-14ae30d7648b

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALLSOURCE SCREENING SOLUTIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18