Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820 - CAROLINA LIQUID CHEMISTRIES CORPORATION

Duns Number:962385787

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More Product Details

Catalog Number

DT88811

Brand Name

Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820

Version/Model Number

DT88820

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

CEM

Product Code Name

ELECTRODE, ION SPECIFIC, POTASSIUM

Device Record Status

Public Device Record Key

3cfb56cf-ad59-4df7-9e18-32bed8c7a942

Public Version Date

May 18, 2020

Public Version Number

1

DI Record Publish Date

May 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAROLINA LIQUID CHEMISTRIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 144
2 A medical device with a moderate to high risk that requires special controls. 183
U Unclassified 7