ABX MINOCLAIR (0.5L) - HORIBA ABX SAS

Duns Number:273647420

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


More Product Details

Catalog Number

-

Brand Name

ABX MINOCLAIR (0.5L)

Version/Model Number

1210401005

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

PPM

Product Code Name

General Purpose Reagent

Device Record Status

Public Device Record Key

c7c3911c-4c43-4177-970c-c1a1adea1e1d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 23, 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