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Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr

Primary DI
06974849369212
Brand
Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr
Company
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Model
20 tests/kit
Published
2022-12-06
Public version status
New
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
06974849369212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974849369212069748493692126974849369212

GMDN Terms#

Term, Definition table
TermDefinition
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of insulin-like growth factor binding protein 1 (IGFBP-1) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the detection of foetal membrane rupture in pregnancy and/or to help predict the risk of preterm or imminent delivery. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560300737
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974849369403EudemonTM AIO800HWTS-AIO800HWTS-EQ0552024-11-14
06974849369076Easy Amp Real-time Fluorescence Isothermal Detection SystemHWTS-1600S2022-12-06
06974849369083Easy Amp Real-time Fluorescence Isothermal Detection SystemHWTS-1600P2022-12-06
06974849369380Macro & Micro-Test Fluorescence Immunoassay AnalyzerHWTS-IF10002024-09-19
06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerHWTS-IF20002024-09-19
06974849369304Macro & Micro-Test HCG Pregnancy Test Midstream1 test/kit2023-11-27
06974849369311Macro & Micro-Test HCG Pregnancy Test Midstream20 tests/kit2023-11-27
06974849369328Macro & Micro-Test HCG Pregnancy Test Midstream3 tests/kit2023-11-27
06974849369335Macro & Micro-Test HCG Pregnancy Test Midstream5 tests/kit2023-11-27
06974849369342Macro & Micro-Test LH Test1 test/kit2023-11-27
06974849369359Macro & Micro-Test LH Test3 tests/kit2023-11-27
06974849369366Macro & Micro-Test LH Test5 tests/kit2023-11-27
06974849369373Macro & Micro-Test LH Test20 tests/kit2023-11-27
06974849369007Macro & Micro-Test Viral DNA/RNA Kit50 tests/kit2022-12-06
06974849369014Macro & Micro-Test Viral DNA/RNA Kit32 tests/kit2022-12-06
06974849369021Macro & Micro-Test Viral DNA/RNA Kit48 tests/kit2022-12-06
06974849369038Macro & Micro-Test Viral DNA/RNA Kit96 tests/kit2022-12-06
06974849369045Macro & Micro-Test Sample Release Reagent50 tests/kit2022-12-06
06974849369052Macro & Micro-Test Automatic Nucleic Acid ExtractorHWTS-NPure322022-12-06
06974849369069Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit50 tubes/kit 2mL2022-12-06

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
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