Catalog Number

-

Brand Name

Arvolife

Version/Model Number

HCG Midstream

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)

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

ae844af2-0ff2-46e9-ba49-4ab14bfa4faf

Public Version Date

April 27, 2018

Public Version Number

1

DI Record Publish Date

March 27, 2018

Package DI Number

10851950008137

Quantity per Package

150

Contains DI Package

00851950008130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-