Catalog Number

REF:207.01.25.02

Brand Name

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

Version/Model Number

25 Tests/Kit

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

-

Product Code

QKO

Product Code Name

Reagent, Coronavirus Serological

Public Device Record Key

61d7f668-2b95-48be-a3b7-23f5ecf74f10

Public Version Date

October 17, 2022

Public Version Number

2

DI Record Publish Date

August 16, 2022

Package DI Number

16973774259800

Quantity per Package

18

Contains DI Package

06973774259803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton