FDA.reportPublic FDA data

Selectra

Primary DI
03661540600395
Brand
Selectra
Company
VitalScientific B.V.
Model
ProM
Catalog number
6003-435
Published
2016-11-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102647000ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...Elitechgroup Vital Scientific BV2011-03-24JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540600395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540600395036615406003953661540600395

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, semi-automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
494028946
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540600357Viva-ProE®6003-7602017-04-21
03661540600418SelectraProS6003-6002016-11-18
03701700860396SelectraProM6003-4352025-05-06
03701700860419SelectraProS6003-6002025-05-06
03701700860358Viva-ProEViva-ProE6003-7602025-04-30
03661540600180V-Twin®6002-8002016-11-21
03661540600050Viva-E®6002-3802016-11-21
03661540600210Viva-Jr®6002-9402016-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00385480574587Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480596961Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480616058Stat Profile NOVA BIOMEDICAL CORPORATIONJGS2022-06-16
00385480646048Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-06-06
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.JGS2020-04-15
00380740156855ARCHITECTABBOTT LABORATORIESJGS2019-10-31
00380740163372ARCHITECTAbbott GmbHJGS2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONJGS2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONJGS2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONJGS2019-02-14
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONJGS2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONJGS2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONJGS2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONJGS2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONJGS2018-12-04
00386100002862Na/K AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONJGS2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONJGS2018-12-04
00386100002985Reference ElectrodeMEDICA CORPORATIONJGS2018-12-04
00386100003029Na/K Solution PackMEDICA CORPORATIONJGS2018-12-04