Catalog Number

MF17

Brand Name

Fastect II Drug Screen Dipstick Test

Version/Model Number

MF17

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 2019

Issuing Agency

In GS1

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

K022355

Product Code

LCM

Product Code Name

Enzyme Immunoassay, Phencyclidine

Public Device Record Key

8e7ddeb2-42bc-4bde-a69b-c2d9f4adf80f

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-