URiSCAN 10 ACR strip - Urinalysis dip and read strips for visual and - YD Diagnostics CORP.

Duns Number:687769737

Device Description: Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Blood, Keton Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Blood, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity), Leucocytes, Microalbumin and Creatinine in urine.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

URiSCAN 10 ACR strip

Version/Model Number

U621

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)

-

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

7f286f31-4373-47d3-98ed-d1f6ae45e4fd

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

August 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"YD DIAGNOSTICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 2