Catalog Number

EIA-3881

Brand Name

Micro-Albumin ELISA

Version/Model Number

EIA-3881

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

K970932

Product Code

JIR

Product Code Name

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

Public Device Record Key

88cd61ef-a9f9-499b-9680-989ad40f4b3e

Public Version Date

March 30, 2020

Public Version Number

2

DI Record Publish Date

June 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-