Catalog Number

-

Brand Name

AICARE

Version/Model Number

HCG Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 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

74e63f49-8282-4294-bcd5-1fc948d6aded

Public Version Date

March 26, 2019

Public Version Number

1

DI Record Publish Date

March 18, 2019

Package DI Number

26970429840120

Quantity per Package

22

Contains DI Package

06970429840126

Package Discontinue Date

March 18, 2019

Package Status

Not in Commercial Distribution

Package Type

-