FDA.reportPublic FDA data

Actim PROM Controls

Primary DI
06430030990622
Brand
Actim PROM Controls
Company
Actim Oy
Model
30800ETUS
Device description
The Actim PROM Controls kit consists of one of each of the following components:1. Actim PROM Negative Control (0 μg/L)2. Actim PROM Low Positive Control (40 μg/L)3. Actim PROM High Positive Control (250 μg/L)4. Actim Reconstitution Solution5. Instructions for use
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
06430030990622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430030990622064300309906226430030990622

GMDN Terms#

Term, Definition table
TermDefinition
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of insulin-like growth factor binding protein 1 (IGFBP-1) in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
06430030990714Actim PROM30821ETUS2019-02-28
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
06430030990714Actim PROMActim OyOAM2019-02-28
06430030990615Actim PROMActim OyOAM2019-02-28
05060169690288IDS-iSYS Insulin like Growth Factor-1 (IGF-1) IMMUNODIAGNOSTIC SYSTEMS LIMITEDOAM2016-04-01