SureFISH 4p16.3 Chr4pTel 403kb P20 GR - SureFISH 4p16.3 Chr4pTel 403kb P20 GR - AGILENT TECHNOLOGIES, INC.

Duns Number:084963177

Device Description: SureFISH 4p16.3 Chr4pTel 403kb P20 GR

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More Product Details

Catalog Number

-

Brand Name

SureFISH 4p16.3 Chr4pTel 403kb P20 GR

Version/Model Number

G110348G

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

MVU

Product Code Name

Reagents, specific, analyte

Device Record Status

Public Device Record Key

bebdd9e9-62f1-4c83-a804-96392efa75cc

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AGILENT TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1076
2 A medical device with a moderate to high risk that requires special controls. 16
3 A medical device with high risk that requires premarket approval 8