Catalog Number

-

Brand Name

Anti-SARS-CoV-2 ELISA (IgA)

Version/Model Number

EI 2606-9601 A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

QKO

Product Code Name

Reagent, Coronavirus Serological

Public Device Record Key

6bc0e0e0-7b83-4888-991e-92d9dddd4f07

Public Version Date

September 24, 2020

Public Version Number

2

DI Record Publish Date

July 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-