Identify Health - Identify Health Drug Screen Test - MEDICAL DISTRIBUTION GROUP INC

Duns Number:064177324

Device Description: Identify Health Drug Screen Test CupAMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD30 Identify Health Drug Screen Test CupAMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ID-H12-2

Brand Name

Identify Health

Version/Model Number

ID-H12-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 30, 2030

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122809,K122809

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

67bd0ed9-eb33-4aa9-b2bc-024c1d518546

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

January 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL DISTRIBUTION GROUP INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8