SPOTCHEM™ II LDH - Strip Description:  For the in vitro quantitative - ARKRAY USA, INC.

Duns Number:008171162

Device Description: Strip Description:  For the in vitro quantitative determination of lactate dehydrogenase ( Strip Description:  For the in vitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples.

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


More Product Details

Catalog Number

-

Brand Name

SPOTCHEM™ II LDH

Version/Model Number

77120

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

K050790,K050790

Product Code Details

Product Code

CFH

Product Code Name

TETRAZOLIUM INT DYE-DIAPHORASE, LACTATE DEHYDROGENASE

Device Record Status

Public Device Record Key

2009f46e-0ee1-432b-84d8-fefc70ae9c3d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARKRAY USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 50