Globe Scientific - SYSMEX: Reaction Tube, for use with Sysmex CA - GLOBE SCIENTIFIC INC.

Duns Number:106793995

Device Description: SYSMEX: Reaction Tube, for use with Sysmex CA Series analyzers

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


More Product Details

Catalog Number

-

Brand Name

Globe Scientific

Version/Model Number

5530

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

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Record Status

Public Device Record Key

0cc9cb27-8ec5-49c1-83a6-3dae3ef4f1dc

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2019

Additional Identifiers

Package DI Number

00840095607773

Quantity per Package

12

Contains DI Package

00840095607766

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"GLOBE SCIENTIFIC 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. 3