FDA.reportPublic FDA data

VITROS

Primary DI
10758750006854
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6801736
Catalog number
6801736
Device description
VITROS Chemistry Products C4 Reagent
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
20758750006851PackageGS136In Commercial Distribution
10758750006854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000685120758750006851
1075875000685410758750006854

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

Regulatory Flags#

DUNS number
623873044
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
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740170196AlinityABBOTT IRELANDDBI2021-05-13
00380740170202ARCHITECTABBOTT IRELANDDBI2021-03-19
00380740175160ARCHITECTAbbott GmbHDBI2020-11-06
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
00380740019747ARCHITECTABBOTT LABORATORIESDBI2016-06-06