Catalog Number

4469658190

Brand Name

Tinaquant Albumin Gen2

Version/Model Number

4469658190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K932950

Product Code

JIR

Product Code Name

INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Public Device Record Key

6a7a477d-c844-43b5-b18d-bfc87cdd3aaf

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-