Arvolife - Clinical Guard

Duns Number:827033924

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More Product Details

Catalog Number

-

Brand Name

Arvolife

Version/Model Number

THC Marijuana Drug Test Strip

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)

Yes

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

770d6f8a-c346-409d-944e-db00db7aae7e

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2018

Additional Identifiers

Package DI Number

10851950008120

Quantity per Package

180

Contains DI Package

00851950008123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CLINICAL GUARD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5