Catalog Number

18000442

Brand Name

Pregnancy-Skreen

Version/Model Number

18000442

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

-

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

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

e5ffffaf-23bf-47dc-9876-a51070395095

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

January 21, 2020

Package DI Number

10810042681078

Quantity per Package

80

Contains DI Package

00810042681071

Package Discontinue Date

February 12, 2020

Package Status

Not in Commercial Distribution

Package Type

Case