FDA.reportPublic FDA data

IDS-iSYS Insulin like Growth Factor-1 (IGF-1)

Primary DI
05060169690288
Brand
IDS-iSYS Insulin like Growth Factor-1 (IGF-1)
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-3900
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
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
05060169690288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169690288050601696902885060169690288

GMDN Terms#

Term, Definition table
TermDefinition
Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin-like growth factor I (IGF1), also referred to as somatomedin C, in a clinical specimen using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Prior to first use. Store the cartridge and calibrators in an upright position in the dark. Do not freeze the cartridge or the calibrators
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
Expiration 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
05060169691148IDS-iSYS SDSpeed CalcIS-SDSCALC2023-06-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060169691148IDS-iSYS SDSpeed CalcIMMUNODIAGNOSTIC SYSTEMS LIMITEDOAM2023-06-27
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