Auto-LIA 48 - Instrument - Fujirebio Europe

Duns Number:297346645

Device Description: Instrument

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More Product Details

Catalog Number

-

Brand Name

Auto-LIA 48

Version/Model Number

80629

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

KPA

Product Code Name

Slide Stainer, Automated

Device Record Status

Public Device Record Key

bb2bb15d-31bf-4066-9bc8-5e3521377b19

Public Version Date

March 03, 2020

Public Version Number

1

DI Record Publish Date

February 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUJIREBIO EUROPE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4