FDA.reportPublic FDA data

VITROS

Primary DI
10758750006809
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6801729
Catalog number
6801729
Device description
VITROS Chemistry Products RF Reagent
Published
2016-08-26
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
DHRSYSTEM, TEST, RHEUMATOID FACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHRSystem, Test, Rheumatoid FactorImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750006806PackageGS136In Commercial Distribution
10758750006809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000680620758750006806
1075875000680910758750006809

GMDN Terms#

Term, Definition table
TermDefinition
Rheumatoid factor IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an agglutination 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
07333066024325EliA RF IgM WellPhadia ABDHR2026-01-29
07333066024332EliA RF IgA WellPhadia ABDHR2026-01-29
07333066024110EliA RF IgM WellPhadia ABDHR2026-01-29
07333066024134EliA RF IgA WellPhadia ABDHR2026-01-29
00850054026941QMedix™Diagnostic Automation, Inc.DHR2025-03-27
04048474027754RF IgM (Rheumatoid Factor) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDHR2024-11-22
00380740170004ARCHITECTABBOTT IRELANDDHR2024-09-13
10673486002423Teco Diagnostics Rheumatoid Factor (RF) Reagent SetTECO DIAGNOSTICSDHR2024-04-01
04048474035834Rheumatoid Factor Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungDHR2023-08-29
00840239035837Rheumatoid Factor Screen ELISADRG International IncDHR2023-08-25
00840239035844RF IgG (Rheumatoid Factor) ELISADRG International IncDHR2023-08-25
00840239035851Rheumatoid Factor IgM ELISADRG International IncDHR2023-08-25
00840239035868Rheumatoid Factor IgA ELISADRG International IncDHR2023-08-25
B3507207100Gold Standard Diagnostics Is-Rheumatoid Factor ELISA Test KitGold Standard Diagnostics CorporationDHR2022-12-03
00894175000381AccuDiag™Diagnostic Automation, Inc.DHR2021-08-26
00894175000336AccuDiag ™Diagnostic Automation, Inc.DHR2021-08-06
B224R201RF LATEX Test KitCENOGENICS CORPORATIONDHR2021-05-27
07333066013138EliA IgM Conjugate 200Phadia ABDHR2021-04-30
07333066014135EliA IgM Conjugate 200Phadia ABDHR2021-04-30
00380740169992AlinityABBOTT IRELANDDHR2021-01-13
00816426021457K-ASSAY® RF Reagent (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCDHR2020-11-03
03610230007402Yumizen C1200 Rheumatoid FactorHORIBA ABX SASDHR2020-05-06
07613336121498Rheumatoid Factors IIRoche Diagnostics GmbHDHR2020-03-05
08426950835189QUANTA Flash RF IgA ReagentsINOVA DIAGNOSTICS, INC.DHR2019-09-20
08426950845249QUANTA Flash RF IgM ReagentsINOVA DIAGNOSTICS, INC.DHR2019-09-20
00380740151058AlinityAbbott GmbHDHR2019-08-12
04048474035841Rheumatoid Factor IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungDHR2019-06-10
04048474035858Rheumatoid Factor IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungDHR2019-06-10
04048474035865Rheumatoid Factor IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungDHR2019-06-10
00404847435849Rheumatoid Factor IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungDHR2019-06-10