Home GUDID 06430030990615 Actim PROM
Primary DI 06430030990615
Brand Actim PROM
Company Actim Oy
Model 30821ETUS
Device description Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives. - One dipstick in a sealed aluminum foil pouch with desiccant. - One sterile polyester swab for specimen collection.
Published 2019-02-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1 Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06430030990608 Package GS1 10 In Commercial Distribution 06430030990615 Package GS1 20 In Commercial Distribution 06430030990714 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06430030990608 06430030990608 6430030990608 06430030990615 06430030990615 6430030990615 06430030990714 06430030990714 6430030990714
GMDN Terms# Term, Definition table Term Definition Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or 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. This test is commonly 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 368646046 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06430030990622 Actim PROM Controls 30800ETUS 2019-02-28 06430030990714 Actim PROM 30821ETUS 2019-02-28
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05060169691148 IDS-iSYS SDSpeed Calc IMMUNODIAGNOSTIC SYSTEMS LIMITED OAM 2023-06-27 06974849369205 Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. OAM 2022-12-06 06974849369212 Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. OAM 2022-12-06 05400569000209 IGF-1 ELISA Diasource Immunoassays S.A. SA OAM 2020-09-11 05400569000520 IGF-1-RIA-CT Diasource Immunoassays S.A. SA OAM 2020-09-11 05400569000087 IGFBP-3 Elisa Diasource Immunoassays S.A. SA OAM 2020-01-09 06430030990714 Actim PROM Actim Oy OAM 2019-02-28 06430030990622 Actim PROM Controls Actim Oy OAM 2019-02-28 05060169690288 IDS-iSYS Insulin like Growth Factor-1 (IGF-1) IMMUNODIAGNOSTIC SYSTEMS LIMITED OAM 2016-04-01