RAPID DIAGNOSTICS METHADONE TEST STRIP - METHADONE TEST STRIP - RAPID DIAGNOSTICS INC

Duns Number:008028248

Device Description: METHADONE TEST STRIP

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More Product Details

Catalog Number

07RD7019

Brand Name

RAPID DIAGNOSTICS METHADONE TEST STRIP

Version/Model Number

07RD7019

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)

Yes

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

DJR

Product Code Name

ENZYME IMMUNOASSAY, METHADONE

Device Record Status

Public Device Record Key

34229678-e0fb-4742-b20b-fad88b15d22c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RAPID DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 250
U Unclassified 1