Catalog Number

-

Brand Name

QTEST K

Version/Model Number

0124

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 14, 2022

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"

Yes

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

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Public Device Record Key

9fcc7e85-df6e-4ea9-a0a3-1aecd0971b2a

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-