Dimension Vista® Flex® reagent cartridge CKI - Creatine Kinase Flex® reagent cartridge, 800 Tests - Siemens Healthcare Diagnostics Inc.

Duns Number:005088112

Device Description: Creatine Kinase Flex® reagent cartridge, 800 Tests

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More Product Details

Catalog Number

K2038

Brand Name

Dimension Vista® Flex® reagent cartridge CKI

Version/Model Number

10464356

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083465,K083465

Product Code Details

Product Code

CGS

Product Code Name

NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Device Record Status

Public Device Record Key

531635dd-10a3-484e-9a35-4ef315e357c8

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 363
2 A medical device with a moderate to high risk that requires special controls. 829
3 A medical device with high risk that requires premarket approval 57
U Unclassified 7