Catalog Number

12-4100-01

Brand Name

Phadia 2500E

Version/Model Number

12-4100-01

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

-

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

K061165

Product Code

NHX

Product Code Name

ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

Public Device Record Key

36a84c85-ec2c-4cc1-bf52-b09fe9e456b7

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

December 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-