Catalog Number

4252340

Brand Name

Autoimmune EIA

Version/Model Number

425-2340

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051492

Product Code

NBT

Product Code Name

ANTIBODIES,SACCHAROMYCES CEREVISIAE (S.CEREVISIAE)

Public Device Record Key

b810962f-c354-4346-8c8d-fec328023fcd

Public Version Date

July 29, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-