Anti-B (Murine Monoclonal) Gamma-clone - This reagent is used in slide, tube and - IMMUCOR, INC.

Duns Number:061446282

Device Description: This reagent is used in slide, tube and microplate tests, for the detection of the B antig This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.

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More Product Details

Catalog Number

0413210

Brand Name

Anti-B (Murine Monoclonal) Gamma-clone

Version/Model Number

0413210

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

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

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

754a8073-1646-46ef-b115-72c72ff061ac

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2014

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