FDA.reportPublic FDA data

IGFBP-3 Elisa

Primary DI
05400569000087
Brand
IGFBP-3 Elisa
Company
Diasource Immunoassays S.A. SA
Model
KAP1171
Device description
IGFBP-3 Elisa
Published
2020-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
05400569000087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400569000087054005690000875400569000087

GMDN Terms#

Term, Definition table
TermDefinition
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin-like growth factor binding protein 3 (IGFBP-3) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458777323
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05400569000209IGF-1 ELISAKAP15812020-09-11
05400569000414KIP1131KIP11312020-09-11
05400569000520IGF-1-RIA-CTKIP15882020-09-11
05400569000407hGH-IRMAKIP10812020-01-15
05400569000117INS ELISAKAP12512020-01-10
05400569000346ANDROSTENEDIONE-RIA-CTKIP04512020-10-05
05400569000452LHsp-IRMAKIP13112020-10-05
05400569000674Estrone-RIA-CTKIPI91002020-09-16
05400569000360E2 RIA CTKIP06292020-09-15
0540056900065011-DESOXYCORTISOL-RIA-CTKIPI200002020-09-15
05400569000049C-PEP-EASIAKPA04012020-09-14
05400569000377FSH IRMAKIP08412020-09-14
05400569000865Androstenedione-ELISAKAPD32652020-09-14
05400569000490PROG-RIA-CTKIP14582020-09-11
05400569001411Trypsin-RIAKIPCE072020-01-29
05400569000322C-PEP II-RIA-CTKIP04092020-01-15
05400569000353DHEA-S-RIA-CTKIP04812020-01-15
05400569000438INS-IRMAKIP1251/KIP12542020-01-15
0540056900047617OHP RIA CTKIP14092020-01-15
05400569000483PRL-IRMAKIP14412020-01-15

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
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