Validate - Validate Tumor Markers is intended for the - Lgc Clinical Diagnostics, Inc.

Duns Number:075886031

Device Description: Validate Tumor Markers is intended for the quantitative determination of Calibration Verif Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.

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More Product Details

Catalog Number

407sa

Brand Name

Validate

Version/Model Number

407sa

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

Yes

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

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Device Record Status

Public Device Record Key

df3bc15c-f058-4925-870a-9ab263a0cdad

Public Version Date

February 24, 2022

Public Version Number

2

DI Record Publish Date

March 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LGC CLINICAL DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 184
2 A medical device with a moderate to high risk that requires special controls. 39