FDA.reportPublic FDA data

Synchron

Primary DI
15099590229733
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
988462
Catalog number
988462
Device description
C3 Reagent (C3 2 x 100)
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
CZWComplement C3, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CZWComplement C3, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032035000SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALIBeckman Coulter, Inc.2003-08-07CZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590229733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022973315099590229733

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C3/C3c IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C3 and/or C3c 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
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
00380740170172AlinityABBOTT IRELANDCZW2021-05-13
00380740170189ARCHITECTABBOTT IRELANDCZW2021-03-26
00380740175153ARCHITECTAbbott GmbHCZW2020-11-06
07613336133590Tina-quant Complement C3c Ver.2Roche Diagnostics GmbHCZW2020-03-05
00380740150662AlinityAbbott GmbHCZW2019-06-27
00630414595665Atellica CH C3Siemens Healthcare Diagnostics Inc.CZW2017-12-27
15099590010560AUBeckman Coulter, Inc.CZW2016-09-24
B1761050Antiserum to Human C-3 (b1c/b1a)KENT LABORATORIES INCCZW2016-09-24
B1761052Anti Human C-3 (b1c/b1a) FITCKENT LABORATORIES INCCZW2016-09-24
B1761190Antiserum to Human C-3 (b1c)KENT LABORATORIES INCCZW2016-09-24
05051700010542Human Complement C3 ‘NL’ BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700010559Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700015578Human C3c Kit for use on the SPAplusTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700017596Optilite C3c KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
00842768005220Dimension® Flex® reagent cartridge C3Siemens Healthcare Diagnostics Inc.CZW2016-09-24
00842768006050Dimension Vista® C3 Complement Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00842768009716N Antiserum to Human C3cSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00842768009723N Antiserum to Human C3cSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00630414517735ADVIA® Chemistry C3 Complement C3 ReagentsSiemens Healthcare Diagnostics Inc.CZW2016-09-24
04015630910274Tinaquant C3cRoche Diagnostics GmbHCZW2016-09-20
04015630917709Tinaquant Complement C3c ver2Roche Diagnostics GmbHCZW2016-09-20
04015630928422Tinaquant Complement C3c ver2Roche Diagnostics GmbHCZW2016-09-20
00813545023829Scanlisa C3d Elisa 96 Test SCIMEDX CORPORATIONCZW2016-09-20
00813545023836C3d Plates & Calibrator Sets SCIMEDX CORPORATIONCZW2016-09-20
05055273201611C3RANDOX LABORATORIES LIMITEDCZW2016-09-16
05700572002482Poly Rb A-Hu C3c Complement/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZW2016-09-16
00816426020078K-ASSAY® Complement C3 ReagentKAMIYA BIOMEDICAL COMPANY, LLCCZW2016-09-16
00817302020922CAROLINA LIQUID CHEMISTRIES CORP.® C3 Complement C3 CC634CAROLINA LIQUID CHEMISTRIES CORPORATIONCZW2016-09-01
15099590230487IMMAGEBeckman Coulter, Inc.CZW2016-08-24
10758750006847VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CZW2016-08-23