Mission U120 Urine Analyzer - Mission U120 Urine Analyzer - ACON LABORATORIES, INC.

Duns Number:781100966

Device Description: Mission U120 Urine Analyzer

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More Product Details

Catalog Number

-

Brand Name

Mission U120 Urine Analyzer

Version/Model Number

U111-101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KQO

Product Code Name

AUTOMATED URINALYSIS SYSTEM

Device Record Status

Public Device Record Key

442db925-059e-4ec7-8799-88d145748260

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACON LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 6