mALB MA2423

GUDID 05055273204537

The product is intended to be used for the quantitative in vitro determination of Microalbumin in urine.

RANDOX LABORATORIES LIMITED

Microalbumin IVD, kit, nephelometry/turbidimetry
Primary Device ID05055273204537
NIH Device Record Key59b9fb69-6ec6-44b5-956f-d1ffee570b1e
Commercial Distribution StatusIn Commercial Distribution
Brand NamemALB
Version Model NumberMA2423
Catalog NumberMA2423
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273204537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DDZAlbumin, Fitc, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [mALB]

05055273209259A Microalbumin test system is a device intended for the quantitative in vitro determination of M
05055273204568A Microalbumin test system is a device intended for the quantitative in vitro determination of M
05055273204551A Microalbumin test system is a device intended for the quantitative in vitro determination of M
05055273204544The product is intended to be used for the quantitative in vitro determination of Microalbumin i
05055273204537The product is intended to be used for the quantitative in vitro determination of Microalbumin i

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