Yumizen C1200 ALP - HORIBA ABX SAS

Duns Number:273647420

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


More Product Details

Catalog Number

-

Brand Name

Yumizen C1200 ALP

Version/Model Number

1300023830

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

K191245

Product Code Details

Product Code

CJE

Product Code Name

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Device Record Status

Public Device Record Key

cb0c0e63-230f-4459-b807-177219580962

Public Version Date

May 14, 2020

Public Version Number

1

DI Record Publish Date

May 06, 2020

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