Dimension Vista® CTNI CAL - Cardiac Troponin I Calibrator, 2x6x1mL - Siemens Healthcare Diagnostics Inc.

Duns Number:005088112

Device Description: Cardiac Troponin I Calibrator, 2x6x1mL

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More Product Details

Catalog Number

KC678

Brand Name

Dimension Vista® CTNI CAL

Version/Model Number

10445197

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 06, 2022

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

K053577

Product Code Details

Product Code

JIT

Product Code Name

CALIBRATOR, SECONDARY

Device Record Status

Public Device Record Key

0577c705-b7a6-49dd-9ff2-a2642b3dc419

Public Version Date

October 07, 2022

Public Version Number

6

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