Dade® PFA Trigger Solution - To aid in the detection of platelet dysfunction - Siemens Healthcare Diagnostics Products GmbH

Duns Number:388240673

Device Description: To aid in the detection of platelet dysfunction in citrated human whole blood

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More Product Details

Catalog Number

B4170-50

Brand Name

Dade® PFA Trigger Solution

Version/Model Number

10445701

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

K060489,K060489

Product Code Details

Product Code

JOZ

Product Code Name

SYSTEM, AUTOMATED PLATELET AGGREGATION

Device Record Status

Public Device Record Key

be8e5fc1-34d5-40de-b210-5be8fd9db5f8

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 PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 101