FDA.reportPublic FDA data

ELICAL 2

Primary DI
03701700817802
Brand
ELICAL 2
Company
VITALSCIENTIFIC
Model
CALI-0550
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701700817802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701700817802037017008178023701700817802

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
267732378
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540214707GAMMA-GT SZASZ SLGZSL-02502016-09-24
03701700819400ELITROL ICONT-00602026-03-04
03701700819509ELITROL IICONT-01602026-03-04
03701700800347LDL CALIBRATOR KIT551152026-02-12
03701700800354HDL CALIBRATOR KIT551192026-02-12
03701700821106HbA1c CALIBRATOR SET HBAC-00432026-01-19
03701700821205HbA1c CONTROL L+ HHBAC-00492026-01-19
03701700800019ENVOY 500 ALBUMIN REAGENT KIT552252025-03-31
03701700815006ALBUMINALBU-02502025-03-31
03701700800026ENVOY 500 ALT REAGENT KIT552152025-03-31
03701700800033ENVOY 500 AMYLASE REAGENT KIT552452025-03-31
03701700800040ENVOY 500 AST REAGENT KIT552502025-03-31
03701700800057ENVOY 500 URIC ACID REAG.KIT554502025-03-31
03701700800064ENVOY 500 DIRECT BILIRUBIN REAGENT KIT552602025-03-31
03701700800071ENVOY 500 TOTAL BILIRUBIN REAGENT KIT552702025-03-31
03701700800088ENVOY 500 CALCIUM REAGENT KIT552872025-03-31
03701700800095ENVOY 500 SERUM CALIBRATOR KIT551112025-03-31
03701700800101ENVOY 500 CHOLESTEROL REAGENT KIT552972025-03-31
03701700800125ENVOY 500 SERUM CONTROL KIT551312025-03-31
03701700800132ENVOY 500 CREATININE REAG KIT553352025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727018977POINTE Chemistry Calibrator SetHORIBA INSTRUMENTS INCORPORATEDJIX2026-05-01
00850083817008Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817015Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817022Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817039Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
00850033167184Smartest Persona II Multi Blood Glucose Monitoring SystemGlobalmed Holdings, LLCJIX2024-12-02
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIX2024-04-03
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414611051Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
00852676007063Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
00380740161378ARCHITECTAbbott GmbHJIX2020-09-18
00817302023213Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2020-05-08
00852676007780Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2020-03-28
00630414284972N Rheumatology Standard SLSiemens Healthcare Diagnostics Products GmbHJIX2020-02-14
04250317522450Plasma Calibrator Set Chromsystems Instruments + Chemicals GmbHJIX2019-07-26
04250317525055Plasma Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2019-07-26
04250317535139Plasma Calibration SetChromsystems Instruments + Chemicals GmbHJIX2019-07-26
04250317542755Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317542809Plasma Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317542854Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543226Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543233Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543370Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22