Home GUDID 00015482771201 SPOTCHEM™ II LDH
Primary DI 00015482771201
Brand SPOTCHEM™ II LDH
Company Arkray USA, Inc.
Model 77120
Device description Strip description for the invitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples
Published 2016-09-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name CFH TETRAZOLIUM INT DYE-DIAPHORASE, LACTATE DEHYDROGENASE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00015482771201 Primary GS1 0 50015482771206 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00015482771201 00015482771201 015482771201 0015482771201 50015482771206 50015482771206
GMDN Terms# Term, Definition table Term Definition Magnesium (Mg2+) IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of magnesium (Mg2+) in a clinical specimen, using a spectrophotometry method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 008171162 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 
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