Catalog Number

DECC056710

Brand Name

EliA SymphonyS Well

Version/Model Number

DECC056710

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

K190710,K190710

Product Code

LLL

Product Code Name

EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL

Public Device Record Key

dd917be5-2de2-473c-bd89-36405f15fdd9

Public Version Date

July 08, 2020

Public Version Number

1

DI Record Publish Date

June 30, 2020

Package DI Number

07333066016108

Quantity per Package

4

Contains DI Package

07333066016115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-