PTS Panels® Cholesterol Test Strips - PTS Panels® Cholesterol test strips are in vitro - POLYMER TECHNOLOGY SYSTEMS, INC.

Duns Number:835772872

Device Description: PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor choles PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

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More Product Details

Catalog Number

1790

Brand Name

PTS Panels® Cholesterol Test Strips

Version/Model Number

1790

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K990688,K990688

Product Code Details

Product Code

CHH

Product Code Name

ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Device Record Status

Public Device Record Key

82933d28-9c28-40f2-8045-cb4697730457

Public Version Date

April 14, 2022

Public Version Number

4

DI Record Publish Date

July 22, 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