CardioChek® Plus Professional Analyzer, Refurbished - The CardioChek® Plus professional analyzer is - POLYMER TECHNOLOGY SYSTEMS, INC.

Duns Number:835772872

Device Description: The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.

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More Product Details

Catalog Number

2702

Brand Name

CardioChek® Plus Professional Analyzer, Refurbished

Version/Model Number

2702

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Device Record Status

Public Device Record Key

bcbfdb1e-62bc-4164-a09f-b3c5f136e866

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

July 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POLYMER TECHNOLOGY SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 1