ihcDirect® SOX10 Ab, 15mL - Clone R1008 - NOVODIAX, INC.

Duns Number:965326957

Device Description: Clone R1008

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More Product Details

Catalog Number

K32040-015

Brand Name

ihcDirect® SOX10 Ab, 15mL

Version/Model Number

K32040-015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2021

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

Yes

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

ca928c30-767d-444a-a848-24c6922f261f

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVODIAX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 245