Clever Choice - Control Solution to apply to Blood Glucose Test - SIMPLE DIAGNOSTICS INC

Duns Number:004135503

Device Description: Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of readings Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of readings from a Blood Glucose meter and/or Test Strips.

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More Product Details

Catalog Number

98302-0001-03

Brand Name

Clever Choice

Version/Model Number

Control

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)

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

fa204ad2-49f7-44a7-9117-17cd90330430

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

10898302001033

Quantity per Package

100

Contains DI Package

00898302001036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SIMPLE DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 19