BOND - LEICA BIOSYSTEMS MELBOURNE PTY LTD

Duns Number:753184944

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More Product Details

Catalog Number

S49.4524

Brand Name

BOND

Version/Model Number

BOND Controller (7.0)

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

-

Product Code Details

Product Code

KPA

Product Code Name

Slide Stainer, Automated

Device Record Status

Public Device Record Key

a953f644-1644-453a-97db-25fc5c416b6b

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEICA BIOSYSTEMS MELBOURNE PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28