FLEX Mono Mo A-Hu CD68 Cl KP1 RTU - FLEX Monoclonal Mouse Anti-Human CD68 Clone KP1 - AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Duns Number:894671143

Device Description: FLEX Monoclonal Mouse Anti-Human CD68 Clone KP1 Ready-to-Use (Dako Autostainer/ Autostaine FLEX Monoclonal Mouse Anti-Human CD68 Clone KP1 Ready-to-Use (Dako Autostainer/ Autostainer Plus)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

FLEX Mono Mo A-Hu CD68 Cl KP1 RTU

Version/Model Number

IS609

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

NJT

Product Code Name

IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Device Record Status

Public Device Record Key

d380f9f6-4ac9-4090-98c8-2802fb14cc81

Public Version Date

December 07, 2020

Public Version Number

2

DI Record Publish Date

September 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AGILENT TECHNOLOGIES SINGAPORE PTE LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 490
2 A medical device with a moderate to high risk that requires special controls. 43
3 A medical device with high risk that requires premarket approval 5