ELITROL II

GUDID 03701700819509

VITALSCIENTIFIC

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device ID03701700819509
NIH Device Record Keyd20ec378-2714-4a12-9dcd-1b12dcb7dd23
Commercial Distribution StatusIn Commercial Distribution
Brand NameELITROL II
Version Model NumberCONT-0160
Company DUNS267732378
Company NameVITALSCIENTIFIC
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103701700819509 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-12
Device Publish Date2026-03-04

On-Brand Devices [ELITROL II]

03701700828501CONT-0180
03701700819509CONT-0160

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