FDA.reportPublic FDA data

Synchron

Primary DI
15099590233372
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
467930
Catalog number
467930
Device description
Immunoglobulin M Reagent (Ig-M 2 x 150)
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
DEWIgg, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEWIgg, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K965108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K965108000SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENTBeckman Instruments, Inc.1997-03-06DEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590233372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023337215099590233372

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
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
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
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740169893AlinityABBOTT IRELANDDEW2021-04-29
00380740169909ARCHITECTABBOTT IRELANDDEW2021-04-02
00380740175184ARCHITECTAbbott GmbHDEW2020-11-06
00630414002903BN II SystemSiemens Healthcare Diagnostics Products GmbHDEW2020-09-24
03610230007358Yumizen C1200 Immunoglobulin GHORIBA ABX SASDEW2020-07-13
07613336121320Tina-quant IgG Gen.2Roche Diagnostics GmbHDEW2020-03-05
00380740153922AlinityAbbott GmbHDEW2019-12-24
03573026619527VIDAS® PC SOFTWARE V4.9BIOMERIEUX SADEW2019-12-20
05055273203967IgGRANDOX LABORATORIES LIMITEDDEW2019-06-03
00842768012167N Cuvette Segments for BN IISiemens Healthcare Diagnostics Products GmbHDEW2017-11-15
00842768012174N Predilution WellsSiemens Healthcare Diagnostics Products GmbHDEW2017-10-31
B1761010Antiserum to Human IgG (gamma chain specific)KENT LABORATORIES INCDEW2016-09-24
05051700010368Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010399Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010443Human IgG - ‘NL’ BINDARID™ Radial Immunodiffusion Kit THE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010917Human IgG1 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010924Human IgG2 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010931Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05055273203936IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203950IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203974IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
00840733101304MERIFLUOR GullSORB MERIDIAN BIOSCIENCE, INC.DEW2016-09-23
04015630913923IGG Immunoglobulin G Turbidimetric)Roche Diagnostics GmbHDEW2016-09-20
04015630919697Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630919710Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630925735Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
05700572000273Poly Rb a Hu Alpha-1-AntitrypsinAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
05700572000860Poly Rb A-Hu IgA, IgG, IgMAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
05700572001386Poly Rb A-Hu IgGAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16