High Range Trace Elements - HR Trace Elements - UTAK LABORATORIES, INC.

Duns Number:092519016

Device Description: HR Trace Elements

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More Product Details

Catalog Number

66815

Brand Name

High Range Trace Elements

Version/Model Number

66815

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Device Record Status

Public Device Record Key

e3ae288d-2381-43d8-8d27-bba999f0cce9

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Additional Identifiers

Package DI Number

B800668155

Quantity per Package

5

Contains DI Package

B800668150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"UTAK LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113