Catalog Number

03P3625

Brand Name

ARCHITECT

Version/Model Number

3P36-25

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

LOK

Product Code Name

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Public Device Record Key

b361e6f0-0bd1-4eb6-a0a7-9bfa9a0da0b2

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

November 18, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-