Catalog Number

-

Brand Name

AIX1000 Analyzer

Version/Model Number

00400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K150358

Product Code

GMQ

Product Code Name

Antigens, Nontreponemal, All

Public Device Record Key

8dc581b9-91f9-484d-9731-e4bdc3ab8a8e

Public Version Date

June 04, 2021

Public Version Number

4

DI Record Publish Date

November 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-