Catalog Number

DECC066630

Brand Name

EliA SARS-CoV-2-Sp1 IgG Well

Version/Model Number

DECC066630

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

-

Product Code

QKO

Product Code Name

Reagent, coronavirus serological

Public Device Record Key

c1e61acb-5c8a-418f-b80f-537301e2d469

Public Version Date

January 29, 2021

Public Version Number

1

DI Record Publish Date

January 21, 2021

Package DI Number

07333066021201

Quantity per Package

4

Contains DI Package

07333066021287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-