Catalog Number

900033000VE

Brand Name

VerséaTM Ophthalmics 4.3” Lateral Flow Reader

Version/Model Number

100033000

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJQ

Product Code Name

Colorimeter, Photometer, Spectrophotometer For Clinical Use

Public Device Record Key

ecf89a39-2aad-449c-8408-8a00ac62bb2e

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Package DI Number

00860009215115

Quantity per Package

1

Contains DI Package

00860009215108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit