FDA.reportPublic FDA data

Q-Prep

Primary DI
15099590563561
Brand
Q-Prep
Company
Beckman Coulter, Inc.
Model
100V
Catalog number
6603740
Device description
COULTER Q-PREP Immunology Workstation
Published
2016-09-23
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
JQWStation, Pipetting And Diluting, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590563561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959056356115099590563561

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVD, automatedA mains electricity (AC-powered) instrument or platform intended to be used for the automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. The device operates with minimal technician involvement and automation of all procedural steps.

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
00850054026392Diagnostic Automation, Inc.Diagnostic Automation, Inc.JQW2025-12-24
08059304340147dIFine P15VISIA LAB SRLJQW2025-06-27
00884999051522Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999048973Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051508Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051515Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051720Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
06975379910028QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910035QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910509QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910025QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910032QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910506QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910011QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
16975379910018QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
06975379910004QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-12
07640137480288Veya Dx 6Tecan Schweiz AGJQW2025-03-31
07640137480295Veya Dx 9Tecan Schweiz AGJQW2025-03-31
07613336180112AVENIO Edge SystemRoche Molecular Systems, Inc.JQW2025-03-25
00819704020388FINDERBaebies, Inc.JQW2025-01-31
00819704020395FINDERBaebies, Inc.JQW2025-01-31
07613336155790AcfS L and D Equipment Installation BundleRoche Molecular Systems, Inc.JQW2025-01-30
07613336172353AcfS Library RobotRoche Molecular Systems, Inc.JQW2025-01-30
07613336172360AcfS Detection RobotRoche Molecular Systems, Inc.JQW2025-01-30
04250289513531HELMED® Automated IFA ProcessorAesku.Diagnostics GmbH & Co. KGJQW2025-01-03
00812589020979FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021051FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021068FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021075FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021082FontusCaliper Life Sciences, Inc.JQW2024-07-02