QUCARE®Self Total Cholesterol - DFI CO.,LTD

Duns Number:688779180

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More Product Details

Catalog Number

-

Brand Name

QUCARE®Self Total Cholesterol

Version/Model Number

6400P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2022

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

b5972d9a-f4b4-4be0-a813-2719e90fc550

Public Version Date

August 02, 2022

Public Version Number

1

DI Record Publish Date

July 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DFI CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13