LIAISON XL MUREX HBcIgM - DIASORIN SPA

Duns Number:630822989

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More Product Details

Catalog Number

-

Brand Name

LIAISON XL MUREX HBcIgM

Version/Model Number

318140

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)

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

e1d279e6-3dcf-4b35-a47f-b563b36d37b6

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Additional Identifiers

Package DI Number

18056771103388

Quantity per Package

10

Contains DI Package

08056771103381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DIASORIN SPA" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 3