Catalog Number

FSWS200

Brand Name

DIASTAT ENA Single Well Screen

Version/Model Number

FSWS200

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LLL

Product Code Name

Extractable Antinuclear Antibody, Antigen And Control

Public Device Record Key

94b2aa89-c030-4f60-9b7c-991238b34ab1

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

August 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-