Lia Pregnancy Test - Lia Diagnostics, Inc.

Duns Number:079828691

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More Product Details

Catalog Number

-

Brand Name

Lia Pregnancy Test

Version/Model Number

2 Pack Discreet

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Device Record Status

Public Device Record Key

a763dc0b-a0bd-4b0f-aa03-7695d823549b

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIA DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2