Origin Instant Drug Test - Origin Instant Drug Test, - ORIGIN DIAGNOSTICS LLC

Duns Number:036225773

Device Description: Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC-pH,SG,OX

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More Product Details

Catalog Number

61007-3-OD

Brand Name

Origin Instant Drug Test

Version/Model Number

61007-3-OD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

4c103ad7-0b11-41ff-8006-f95910326a6c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORIGIN DIAGNOSTICS 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