Catalog Number

-

Brand Name

HCG TEST STRIP

Version/Model Number

HCG3.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 26, 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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

745c8bc7-c3c3-4c90-a17c-a6be3ba6200f

Public Version Date

January 02, 2020

Public Version Number

1

DI Record Publish Date

December 25, 2019

Package DI Number

16970429840154

Quantity per Package

100

Contains DI Package

06970429840157

Package Discontinue Date

December 26, 2019

Package Status

Not in Commercial Distribution

Package Type

-