Catalog Number

07D5822

Brand Name

ARCHITECT

Version/Model Number

7D58-22

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

-

Product Code

JFJ

Product Code Name

CATALYTIC METHODS, AMYLASE

Public Device Record Key

be83dcd9-86df-4c3b-88a6-fd06f48fa2ba

Public Version Date

June 22, 2020

Public Version Number

2

DI Record Publish Date

November 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-