FDA.reportPublic FDA data

IDS-iSYS SDSpeed Calc

Primary DI
05060169691148
Brand
IDS-iSYS SDSpeed Calc
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-SDSCALC
Published
2023-06-27
Public version status
New
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
OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-1Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169691148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169691148050601696911485060169691148

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401915190660info.uk@idsplc.com

Regulatory Flags#

DUNS number
494268600
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060169690721IDS-iSYS Total TestosteroneN/AIS-50002026-04-17
05060169690875IDS-iSYS Total Testosterone Control SetN/AIS-50302026-04-17
05060169691063IDS-iSYS Total Testosterone Calibration VerifiersN/AIS-50352026-04-17
05060169691230IDS-iSYS Free TestosteroneIS-53002025-11-03
05060169691247IDS-iSYS Free Testosterone Control SetIS-53302025-11-03
05060169691254IDS-iSYS Free Testosterone Calibration VerifiersIS-53352025-11-03
05060169693968IDS-i10IS-8104002023-06-27
05060169691223IDS-iSYS Multi Discipline Automated SystemIS-3104002016-04-01
05060169695986IDS Beta CrossLaps® (CTX-I)IS-3000N2024-01-03
05060169696013IDS Beta CrossLaps® (CTX-I) Calibrator SetIS-3020N2024-01-03
05060169696051IDS Beta CrossLaps® (CTX-I) Control SetIS-3030N2024-01-03
05060169696457IDS ACTH IIIS-4500NG2023-08-23
05060169696495IDS ACTH II Calibrator SetIS-4520NG2023-08-23
05060169696532IDS ACTH II Control SetIS-4530NG2023-08-23
05060169691261IDS AndrostenedioneIS-54002023-06-27
05060169691278IDS Androstenedione Control SetIS-54302023-06-27
05060169692305IDS-iSYS D-Sorb SolutionIS-DS2002023-06-27
05060169693913IDS Top Cap SetIS-CAP3002023-06-27
05060169696099IDS Androstenedione Calibrator SetIS-54202023-06-27
05060169690141Urine CrossLaps® (CTX-I) EIAAC-03F12023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974849369205 Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (ImmunochrJiangsu Macro & Micro-Test Med-Tech Co., Ltd.OAM2022-12-06
06974849369212 Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (ImmunochrJiangsu Macro & Micro-Test Med-Tech Co., Ltd.OAM2022-12-06
05400569000209IGF-1 ELISADiasource Immunoassays S.A. SAOAM2020-09-11
05400569000520IGF-1-RIA-CTDiasource Immunoassays S.A. SAOAM2020-09-11
05400569000087IGFBP-3 ElisaDiasource Immunoassays S.A. SAOAM2020-01-09
06430030990714Actim PROMActim OyOAM2019-02-28
06430030990622Actim PROM ControlsActim OyOAM2019-02-28
06430030990615Actim PROMActim OyOAM2019-02-28
05060169690288IDS-iSYS Insulin like Growth Factor-1 (IGF-1) IMMUNODIAGNOSTIC SYSTEMS LIMITEDOAM2016-04-01