Mission Urinalysis Reagent Strips - Mission Urinalysis Reagent Strips (PH) - ACON LABORATORIES, INC.

Duns Number:781100966

Device Description: Mission Urinalysis Reagent Strips (PH)

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More Product Details

Catalog Number

-

Brand Name

Mission Urinalysis Reagent Strips

Version/Model Number

U031-011

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

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 Details

Product Code

CEN

Product Code Name

DYE-INDICATOR, PH (URINARY, NON-QUANT.)

Device Record Status

Public Device Record Key

56a64f14-e638-4d58-a845-d406d8e99f66

Public Version Date

July 22, 2019

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