FDA.reportPublic FDA data

Synchron

Primary DI
15099590233471
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
472055
Catalog number
472055
Device description
PVT5
Published
2016-08-24
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
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590233471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023347115099590233471

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405012282Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012299Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012367Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012374Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012381Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012398Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012404Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012480Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014095Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014132Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014217Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014224Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405016716Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017065Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017072Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017089Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017362Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405019298Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023233Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023257Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023264Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023318Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023325Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023974Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405024421Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07