AutoDELFIA Unconjugated Estriol (uE3) kit - Time-resolved fluoroimmunoassay for the - Wallac Oy

Duns Number:540156544

Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).

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More Product Details

Catalog Number

B083-212

Brand Name

AutoDELFIA Unconjugated Estriol (uE3) kit

Version/Model Number

B083-212

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 20, 2018

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)

-

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

CGI

Product Code Name

Radioimmunoassay, Estriol

Device Record Status

Public Device Record Key

295040f8-7f88-42e7-bb83-8f6ac04d051a

Public Version Date

December 18, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2016

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