Catalog Number

8632810

Brand Name

NOVEOS Capture Reagent Pack Meadow Fescue, Festuca elatior

Version/Model Number

G004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PUW

Product Code Name

System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens

Public Device Record Key

06460043-f481-4150-8cd8-870c73d4852d

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-