Catalog Number

USSCup-10M

Brand Name

UScreen®

Version/Model Number

USSCup-10M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182701,K182701

Product Code

LCM

Product Code Name

Enzyme Immunoassay, Phencyclidine

Public Device Record Key

6cc3f449-fdfd-4b1e-b6de-422c9e686687

Public Version Date

October 31, 2022

Public Version Number

5

DI Record Publish Date

January 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-