FDA.reportPublic FDA data

SelectaLyte (Chloride Electrode)

Primary DI
00850229007348
Brand
SelectaLyte (Chloride Electrode)
Company
AWARENESS TECHNOLOGY, INCORPORATED
Model
3910
Published
2019-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CGZElectrode, Ion-Specific, Chloride

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171476000SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.2018-02-27JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850229007348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850229007348008502290073488502290073480850229007348

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, kit, ion-selective electrode (ISE)A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071065130
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850229007089StatFax 22002023-06-05
00850229007010StatFax47002023-06-05
00850229007027StatFax45002023-06-05
00850229007034StatFax42002023-06-05
00850229007041StatFax33002023-06-05
00850229007072StatFax26002023-06-05
00850229007102StatFax1904+2023-06-05
00850229007126LumiStat49002023-06-05
00850229007140LuMate44002023-06-05
00850229007201ChroMate43002023-06-05
00850229007218ChemWell-T46202023-06-05
00850229007232ChemWell29102023-06-05
00850229007461ChemWell251002023-06-05
00850229007119Redi-Check Photometer QCRedi-Check Photometer QCE3052016-06-30
00850229007164DriDye 492492E002-4922016-06-30
00850229007171DriDye 450450E002-4502016-06-30
00850229007188DriDye 405/ 450405/ 4502016-06-30
00850229007195DriDye 405405E002-4052016-06-30
00850229007225ChemWell® FUSION480048002022-03-03
00850229007287SelectaLyte39102019-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESCGZ2025-10-08
10758750031658VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CGZ2023-04-28
00385480616218Stat ProfileNOVA BIOMEDICAL CORPORATIONCGZ2022-12-07
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CGZ2020-04-15
00386100002282ISE Reagent PackMEDICA CORPORATIONCGZ2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONCGZ2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCGZ2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCGZ2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCGZ2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCGZ2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCGZ2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCGZ2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCGZ2018-12-11
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONCGZ2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCGZ2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCGZ2018-12-04
00380740121686AlinityAbbott GmbHCGZ2018-05-30
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807612GEM Premier 5000 PAK BG/ISE/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807636GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807643GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807674GEM Premier 5000 PAK BG/ISE/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807681GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807698GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807704GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24