IH-Card ABO/RhD(DVI+) - Blood Grouping Reagent; Gel card for use with - Bio-Rad Medical Diagnostics GmbH

Duns Number:312576506

Device Description: Blood Grouping Reagent; Gel card for use with IH-system; Card for ABO/RhD (DVI+) antigen Blood Grouping Reagent; Gel card for use with IH-system; Card for ABO/RhD (DVI+) antigen typing and direct antiglobulin test; 288 cards of 6 microtubes

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More Product Details

Catalog Number

813132100

Brand Name

IH-Card ABO/RhD(DVI+)

Version/Model Number

813132100

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

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

12fca47e-4152-45ca-a9e8-2eb6758dde45

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

January 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD MEDICAL DIAGNOSTICS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 38
U Unclassified 21