FDA.reportPublic FDA data

ADVIA® Chemistry C3 Complement C3 Reagents

Primary DI
00630414517735
Brand
ADVIA® Chemistry C3 Complement C3 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10309053
Catalog number
3060444
Device description
C3 - ADVIA Chem. - RGT - 2x100 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K000469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000469000RANDOX COMPLEMENT C3Randox Laboratories, Ltd.2000-03-27CZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414517735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414517735006304145177356304145177350630414517735

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

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
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
15099590229733SynchronBeckman Coulter, Inc.CZW2016-08-24
15099590230487IMMAGEBeckman Coulter, Inc.CZW2016-08-24
10758750006847VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CZW2016-08-23