FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740175160
Brand
ARCHITECT
Company
Abbott GmbH
Model
9D97-22
Catalog number
09D9722
Device description
Complement C4
Published
2020-11-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBICOMPLEMENT C4, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBIComplement C4, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740175160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740175160003807401751603807401751600380740175160

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C4/C4c IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C4 and/or C4c in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740170196AlinityABBOTT IRELANDDBI2021-05-13
00380740170202ARCHITECTABBOTT IRELANDDBI2021-03-19
07613336133606Tina-quant Complement C4 Ver.2Roche Diagnostics GmbHDBI2020-03-05
00380740150679AlinityAbbott GmbHDBI2019-06-27
00630414595658Atellica CH C4Siemens Healthcare Diagnostics Inc.DBI2017-12-27
15099590010577AUBeckman Coulter, Inc.DBI2016-09-24
B1761090Antiserum to Human C-4 (b1e)KENT LABORATORIES INCDBI2016-09-24
B1761092Anti Human Complement C4 (b1e) FITCKENT LABORATORIES INCDBI2016-09-24
05051700015585Human C4 Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDBI2016-09-24
05051700017602Optilite C4 KitTHE BINDING SITE GROUP LIMITEDDBI2016-09-24
00842768005237Dimension® Flex® reagent cartridge C4Siemens Healthcare Diagnostics Inc.DBI2016-09-24
00842768006067Dimension Vista® C4 Complement Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00842768009693N Antiserum to Human C4Siemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00842768009709N Antiserum to Human C4Siemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 ReagentsSiemens Healthcare Diagnostics Inc.DBI2016-09-24
04015630910267Tinaquant C4Roche Diagnostics GmbHDBI2016-09-20
04015630917716Tinaquant Complement C4 ver2Roche Diagnostics GmbHDBI2016-09-20
04015630928460Tinaquant Complement C4 ver2Roche Diagnostics GmbHDBI2016-09-20
05055273201628C4RANDOX LABORATORIES LIMITEDDBI2016-09-16
05700572002420Poly Rb A-Hu C4c Complement/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDBI2016-09-16
00816426020085K-ASSAY® Complement C4 ReagentKAMIYA BIOMEDICAL COMPANY, LLCDBI2016-09-16
00817302020939CAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635CAROLINA LIQUID CHEMISTRIES CORPORATIONDBI2016-09-01
15099590229726SynchronBeckman Coulter, Inc.DBI2016-08-24
15099590230449IMMAGEBeckman Coulter, Inc.DBI2016-08-24
10758750006854VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DBI2016-08-23
00380740019747ARCHITECTABBOTT LABORATORIESDBI2016-06-06