Catalog Number

DECC055990

Brand Name

EliA RNA Pol III Well

Version/Model Number

DECC055990

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

K202541,K202541

Product Code

NYO

Product Code Name

Autoantibodies, anti-ribonucleic acid polymerase (rnap) iii antibody

Public Device Record Key

2890fba1-424d-433a-936e-5c267593d3da

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 08, 2021

Package DI Number

07333066014913

Quantity per Package

2

Contains DI Package

07333066015583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-