APC/Fire™ 750 anti-human CD56 - URL: - BIOLEGEND, INC.

Duns Number:119240658

Device Description: URL: https://www.biolegend.com/en-us/products/apc-fire750-anti-human-cd56-21455?Clone=QA17 URL: https://www.biolegend.com/en-us/products/apc-fire750-anti-human-cd56-21455?Clone=QA17A16

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More Product Details

Catalog Number

985904

Brand Name

APC/Fire™ 750 anti-human CD56

Version/Model Number

985904

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

dc9ed3c7-84eb-472a-a978-85c9b4bdbd98

Public Version Date

April 20, 2022

Public Version Number

1

DI Record Publish Date

April 12, 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