FDA.reportPublic FDA data

IMMAGE

Primary DI
15099590265403
Brand
IMMAGE
Company
Beckman Coulter, Inc.
Model
A15445
Device description
IMMAGE 800
Published
2020-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JQXNephelometer, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQXNephelometer, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590265403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959026540315099590265403

GMDN Terms#

Term, Definition table
TermDefinition
Nephelometry/turbidimetry analyser IVD, manualAn electrically-powered manual laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of light absorption and/or light scatter caused by particles (e.g., bacteria) and/or other biological components suspended in a clinical specimen using a photometric detection system. It is generally used to measure the concentration of a target analyte in solution.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904440640BD Kiestra™ ID AST Calibrator KitBECTON, DICKINSON AND COMPANYJQX2024-08-29
05032384474516SENSITITRE NEPHELOMETERTREK DIAGNOSTIC SYSTEMS LIMITEDJQX2022-12-14
00382902450153BD BBL™ CrystalSpec™ Calibration TubesBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904409104BD PhoenixSpec™ NephelometerBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904409111BD PhoenixSpec™ Calibrator KitBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904413552BD PhoenixSpec™ Calibrator 0.25 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904413569BD PhoenixSpec™ Calibrator 0.50 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904419516BD PhoenixSpec™ AP Calibrator KitBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904419530BD PhoenixSpec™ Calibrator 2.0 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904480103BD Phoenix™ APBECTON, DICKINSON AND COMPANYJQX2018-05-25