Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green) - Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific - ALBA BIOSCIENCE LIMITED

Duns Number:516536641

Device Description: Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the direct antiglo Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG and/or C3b and/or C3d components.Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG and/or C3b and/or C3d components.

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More Product Details

Catalog Number

-

Brand Name

Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green)

Version/Model Number

Z350U

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

0069ebe6-4485-4559-9fb2-cef2c102d898

Public Version Date

March 31, 2022

Public Version Number

6

DI Record Publish Date

February 16, 2018

Additional Identifiers

Package DI Number

05060242471575

Quantity per Package

10

Contains DI Package

05060242471636

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ALBA BIOSCIENCE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8