ADVIA® Chemistry MYO Myoglobin Reagents - Myoglobin - ADVIA Chem. - RGT - 2x100 tests - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: Myoglobin - ADVIA Chem. - RGT - 2x100 tests

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More Product Details

Catalog Number

4862455

Brand Name

ADVIA® Chemistry MYO Myoglobin Reagents

Version/Model Number

10361939

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 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

K122599

Product Code Details

Product Code

DDR

Product Code Name

MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Device Record Status

Public Device Record Key

b71f8257-0b17-476b-84ab-b660f9b0fa83

Public Version Date

August 04, 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