SureFISH 22q13.1 PDGFB DF 919kb P100 GR - SureFISH 22q13.1 PDGFB DF 919kb P100 GR - AGILENT TECHNOLOGIES, INC.

Duns Number:084963177

Device Description: SureFISH 22q13.1 PDGFB DF 919kb P100 GR

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More Product Details

Catalog Number

-

Brand Name

SureFISH 22q13.1 PDGFB DF 919kb P100 GR

Version/Model Number

G110157G

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

0c86fd0d-282a-4b4d-b8d7-f3e9a338a4a7

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