Catalog Number

T03-3686-54

Brand Name

ADVIA® 120/2120/2120i TESTpoint Low Control

Version/Model Number

10312287

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K896154

Product Code

JCN

Product Code Name

CONTROL, CELL COUNTER, NORMAL AND ABNORMAL

Public Device Record Key

fc71e899-9cf8-4445-bba1-bbccd9a8c8c9

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-