FDA.reportPublic FDA data

IDS-iSYS Trigger Set

Primary DI
05425030421024
Brand
IDS-iSYS Trigger Set
Company
Immunodiagnostic Systems SA
Model
IS-CT100
Published
2016-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425030421024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425030421024054250304210245425030421024

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, 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 more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Store in an upright position in the dark at 15 to 25 degrees celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+32042522636info.be@idsplc.com

Regulatory Flags#

DUNS number
372668418
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05425030426012IDS-iSYS Cartridge Check System (CCS)IS-60102016-04-01
05425030421017IDS-iSYS System Liquid (Syst. l)IS-CS1002016-04-01
05425030421031IDS-iSYS Wash Solution (Wash S)IS-CW1002016-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024548NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.JJE2026-05-15
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.JJE2026-01-23
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22