Catalog Number

05P0721

Brand Name

ARCHITECT

Version/Model Number

5P07-21

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

K123271

Product Code

DLZ

Product Code Name

ENZYME IMMUNOASSAY, PHENOBARBITAL

Public Device Record Key

c81e6010-877b-490a-b010-79dfd66e01b9

Public Version Date

October 21, 2019

Public Version Number

5

DI Record Publish Date

June 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-