Catalog Number

FASM200

Brand Name

DIASTST anti-Sm

Version/Model Number

FASM200

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

K905191

Product Code

LKP

Product Code Name

Anti-Sm Antibody, Antigen And Control

Public Device Record Key

0886e0dd-56e7-4564-b231-487a6a7a2abf

Public Version Date

July 06, 2018

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

-