MICROALBUMIN (mALB)

GUDID 05055273209242

RANDOX LABORATORIES LIMITED

Microalbumin IVD, kit, nephelometry/turbidimetry
Primary Device ID05055273209242
NIH Device Record Key7a787dd1-2f82-4b4c-bbfc-a37f3458709a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICROALBUMIN (mALB)
Version Model NumberMA8056
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273209242 [Primary]

FDA Product Code

DDZAlbumin, Fitc, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-11
Device Publish Date2019-06-03

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