Catalog Number

06K4241

Brand Name

ARCHITECT

Version/Model Number

06K4241

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)

Yes

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

K050493

Product Code

DGC

Product Code Name

IGE, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

532bcfd4-8f55-4a8e-92e4-64a9693c34d5

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-