Antiserum to Human Ceruloplasmin - Goat antiserum to Human Ceruloplasmin - KENT LABORATORIES INC

Duns Number:093642254

Device Description: Goat antiserum to Human Ceruloplasmin

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More Product Details

Catalog Number

126002

Brand Name

Antiserum to Human Ceruloplasmin

Version/Model Number

1

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

DDB

Product Code Name

Ceruloplasmin, Antigen, Antiserum, Control

Device Record Status

Public Device Record Key

e25baf23-7e52-497b-9060-4ad9d78896bc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KENT LABORATORIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 61