COULTER CLONE KC56 (T-200)-FITC - COULTER CLONE KC56 (T-200)-FITC (Analyte - Beckman Coulter, Inc.

Duns Number:008254708

Device Description: COULTER CLONE KC56 (T-200)-FITC (Analyte Specific Reagent)

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More Product Details

Catalog Number

6603838

Brand Name

COULTER CLONE KC56 (T-200)-FITC

Version/Model Number

6603838

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

MVU

Product Code Name

Reagents, Specific, Analyte

Device Record Status

Public Device Record Key

0573dab1-daa8-4746-babe-1511bf17dd46

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECKMAN COULTER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 319
2 A medical device with a moderate to high risk that requires special controls. 503
3 A medical device with high risk that requires premarket approval 9
U Unclassified 1