PE/Dazzle™ 594 anti-human CD117 (c-kit) - URL: - BIOLEGEND, INC.

Duns Number:119240658

Device Description: URL: https://www.biolegend.com/en-us/products/pedazzle-594-anti-human-cd117-c-kit-21679

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More Product Details

Catalog Number

983314

Brand Name

PE/Dazzle™ 594 anti-human CD117 (c-kit)

Version/Model Number

983314

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

fa8461da-0ae7-44cb-9383-3068bb205daf

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOLEGEND, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 209