Actim PROM

Primary DI
06430030990714
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123986000ACTIM PROMAlere Scarborough, Inc.2014-01-09OAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430030990608PackageGS110In Commercial Distribution
06430030990615PackageGS120In Commercial Distribution
06430030990714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430030990608064300309906086430030990608
06430030990615064300309906156430030990615
06430030990714064300309907146430030990714

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
368646046
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430030990622Actim PROM Controls30800ETUS2019-02-28
06430030990615Actim PROM30821ETUS2019-02-28

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
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