IH-Titration Rack - IH-Titration Rack is a rack with empty wells for - Bio-Rad Medical Diagnostics GmbH

Duns Number:312576506

Device Description: IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-50 IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500.

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More Product Details

Catalog Number

813550100

Brand Name

IH-Titration Rack

Version/Model Number

813550100

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)

-

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

KSG

Product Code Name

Media, Potentiating For In Vitro Diagnostic Use

Device Record Status

Public Device Record Key

df63cbb2-defa-4706-8a87-e048669d2ec6

Public Version Date

March 17, 2022

Public Version Number

1

DI Record Publish Date

March 09, 2022

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