Leica Biosystems CytoVision CV TERMINAL SERVER USER LICENSE K/F - CV TERMINAL SERVER USER LICENSE K/F - Leica Biosystems Richmond, Inc.

Duns Number:082930884

Device Description: CV TERMINAL SERVER USER LICENSE K/F

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More Product Details

Catalog Number

-

Brand Name

Leica Biosystems CytoVision CV TERMINAL SERVER USER LICENSE K/F

Version/Model Number

23SWRRMTKFX016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042542

Product Code Details

Product Code

JOY

Product Code Name

DEVICE, AUTOMATED CELL-LOCATING

Device Record Status

Public Device Record Key

412f068c-9b86-4a09-b014-651fad87e957

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEICA BIOSYSTEMS RICHMOND, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 206