Catalog Number

ABTOFSWAE0501A

Brand Name

iSCREEN™

Version/Model Number

ABTOFSWAE0501A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LCM

Product Code Name

Enzyme Immunoassay, Phencyclidine

Public Device Record Key

814943da-ce88-4d70-bae0-52703604dcb3

Public Version Date

June 17, 2022

Public Version Number

1

DI Record Publish Date

June 09, 2022

Package DI Number

30817405022206

Quantity per Package

4

Contains DI Package

00817405022205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton