Catalog Number

-

Brand Name

AIM ASO TEST

Version/Model Number

31050

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

Yes

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

GTQ

Product Code Name

Antistreptolysin - Titer/Streptolysin O Reagent

Public Device Record Key

458aa0fa-ff88-464c-bdd3-4056e7a2a486

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-