CytoCell myProbes - VHL in Orange Spectrum - CYTOCELL LIMITED

Duns Number:232477914

Device Description: VHL in Orange Spectrum

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


More Product Details

Catalog Number

-

Brand Name

CytoCell myProbes

Version/Model Number

MPP5141

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

b8969933-b57f-448e-9735-66d233d762b6

Public Version Date

September 29, 2022

Public Version Number

2

DI Record Publish Date

September 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CYTOCELL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 788
2 A medical device with a moderate to high risk that requires special controls. 16