CLIAWAIVED INC - CoronaChek COVID-19 IgG/IgM Rapid Test Cassette - Cliawaived, Inc.

Duns Number:969635304

Device Description: CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)

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More Product Details

Catalog Number

CLIA-INGM-MC42

Brand Name

CLIAWAIVED INC

Version/Model Number

CLIA-INGM-MC42

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

782d4203-6c9e-4f04-968a-b71742011631

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLIAWAIVED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 1