Q-STAIN® QSX-Enh-F PTH - Clone C123 - NOVODIAX, INC.

Duns Number:965326957

Device Description: Clone C123

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More Product Details

Catalog Number

QF31028-004

Brand Name

Q-STAIN® QSX-Enh-F PTH

Version/Model Number

QF31028-004

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

51be555e-3dfd-465d-828f-5e828d77c07d

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

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