DELFIA Diluent II - For use with the AutoDELFIA® and the DELFIA® kits - Wallac Oy

Duns Number:540156544

Device Description: For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

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More Product Details

Catalog Number

B132-100

Brand Name

DELFIA Diluent II

Version/Model Number

B132-100

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

PPM

Product Code Name

General Purpose Reagent

Device Record Status

Public Device Record Key

28e275fb-1fd5-4c95-9693-af8af3ad76c2

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WALLAC OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 57
2 A medical device with a moderate to high risk that requires special controls. 38
3 A medical device with high risk that requires premarket approval 2