Catalog Number

-

Brand Name

Syntron QuikStrip

Version/Model Number

9010

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)

-

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

a56fbf3a-f1b0-4bc8-967d-14c12bf0093f

Public Version Date

August 16, 2021

Public Version Number

4

DI Record Publish Date

August 18, 2017

Package DI Number

10748349000394

Quantity per Package

50

Contains DI Package

00748349000397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit Box