CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692 - CKMB 2 x 60 tests - CAROLINA LIQUID CHEMISTRIES CORPORATION

Duns Number:962385787

Device Description: CKMB 2 x 60 tests

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More Product Details

Catalog Number

CC692

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692

Version/Model Number

CC692

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CGS

Product Code Name

NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Device Record Status

Public Device Record Key

474ff86a-bf1e-403e-b49f-992dcc45fc93

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 12, 2016

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