ELICAL 2

GUDID 03701700817802

VITALSCIENTIFIC

Multiple-type clinical chemistry analyte profile IVD, calibrator
Primary Device ID03701700817802
NIH Device Record Keybd501e28-0391-4329-892b-f2628fd62367
Commercial Distribution StatusIn Commercial Distribution
Brand NameELICAL 2
Version Model NumberCALI-0550
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
GS103701700817802 [Primary]

FDA Product Code

JIXCalibrator, Multi-Analyte Mixture

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 [ELICAL 2 ]

03701700828303CALI-0580
03701700817802CALI-0550

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