FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740019730
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
9D96-21
Catalog number
09D9621
Device description
CLIN CHEM C3 REAGENT
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740019730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740019730003807400197303807400197300380740019730

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C3/C3c IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of complement cascade components C3 and/or C3c in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06

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
15099590229733SynchronBeckman Coulter, Inc.CZW2016-08-24
15099590230487IMMAGEBeckman Coulter, Inc.CZW2016-08-24