Diff-Quik™ Fixative - Siemens Healthcare Diagnostics Products GmbH

Duns Number:388240673

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More Product Details

Catalog Number

B4132-10A

Brand Name

Diff-Quik™ Fixative

Version/Model Number

10459379

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2018

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

-

Product Code Details

Product Code

KQC

Product Code Name

STAINS, HEMATOLOGY

Device Record Status

Public Device Record Key

94dc59e5-a7b7-4344-b840-a9cbece2ba4f

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2018

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