MassTrak - MassTrak™ Endocrine Steroid Calibrator Set - WATERS TECHNOLOGIES CORPORATION

Duns Number:107186004

Device Description: MassTrak™ Endocrine Steroid Calibrator Set

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More Product Details

Catalog Number

186009311IVD

Brand Name

MassTrak

Version/Model Number

186009311IVD

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)

-

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

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Device Record Status

Public Device Record Key

88d9def0-f19c-4bd9-bc36-7fd1d45b7ca7

Public Version Date

November 01, 2022

Public Version Number

2

DI Record Publish Date

October 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WATERS TECHNOLOGIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 3