CUVETTE SEGMENTS RACK - HORIBA ABX SAS

Duns Number:273647420

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

CUVETTE SEGMENTS RACK

Version/Model Number

1220001891

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)

-

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

JJE

Product Code Name

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device Record Status

Public Device Record Key

43b6a1c1-7e4c-4d18-aa03-1f4d8e1eabd2

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HORIBA ABX SAS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 100