FREND - The COVID-19 total Ab Control LQ is designed to - NanoEnTek, Inc.

Duns Number:687910463

Device Description: The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 tota The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard.

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More Product Details

Catalog Number

FIC-COALQ

Brand Name

FREND

Version/Model Number

COVID-19 total Ab Control LQ

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

-

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 Details

Product Code

QKO

Product Code Name

Reagent, Coronavirus Serological

Device Record Status

Public Device Record Key

5d6bc5c0-6896-42db-bbfd-103a3ab95a07

Public Version Date

November 04, 2020

Public Version Number

2

DI Record Publish Date

September 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANOENTEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 16