Monoclonal Control - Monoclonal Control is intended to be used as a - IMMUCOR, INC.

Duns Number:061446282

Device Description: Monoclonal Control is intended to be used as a control for Immucor low protein Blood Group Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials.

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More Product Details

Catalog Number

0066089

Brand Name

Monoclonal Control

Version/Model Number

0066089

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

BK040010

Product Code Details

Product Code

KSF

Product Code Name

Kit, Quality Control For Blood Banking Reagents

Device Record Status

Public Device Record Key

b68c93b7-8b51-4e69-b6c9-816ee3446864

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUCOR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 58
U Unclassified 3