Immunoassay Control Level 1 - Immunoassay Control Level 1 - CLINIQA CORPORATION

Duns Number:078742335

Device Description: Immunoassay Control Level 1

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Immunoassay Control Level 1

Version/Model Number

94101

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083554

Product Code Details

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Device Record Status

Public Device Record Key

1e81a61b-54a9-4812-95ab-12c2d197c880

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

August 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINIQA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 4