CKMB UDR - The CKMB UDR assay is an in vitro diagnostic test - SENTINEL CH. SPA

Duns Number:429572365

Device Description: The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determ The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC600, DxC800 and Synchron LX20 systems of the CK-MB isoenzyme activity of creatine kinase in serum and Li-heparin plasma by inhibition method.

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More Product Details

Catalog Number

A53720

Brand Name

CKMB UDR

Version/Model Number

A53720

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

K102706

Product Code Details

Product Code

JHS

Product Code Name

Differential Rate Kinetic Method, Cpk Or Isoenzymes

Device Record Status

Public Device Record Key

7d8737c3-c7f4-4d35-9ab7-066bd31728a0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SENTINEL CH. SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 16