FDA.reportPublic FDA data

RHEUMATEX®

Primary DI
10859035006009
Brand
RHEUMATEX®
Company
ALERE NORTH AMERICA, LLC
Model
34S2
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10859035006009PrimaryGS10
00859035006002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085903500600910859035006009
00859035006002008590350060028590350060020859035006002

GMDN Terms#

Term, Definition table
TermDefinition
Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple antibodies associated with rheumatoid arthritis in a clinical specimen, using a multiplex method. The assayed antibodies may include autoimmune antibodies directed at rheumatoid factor (RF) and/or cyclic citrullinated peptide.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-877-441-7440TS.SCR@alere.com

Regulatory Flags#

DUNS number
826027364
Device count
100
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859035006023DENCOCCULT™ IIIL103E2016-09-24
10859035006016IMMUNEX CRP® 71S22016-09-24
10859035006238Acceava® Mono Cassette924072016-09-24
10859035006214Wampole ColorCard® ASO 470502018-09-24
10859035006221Wampole ColorCard® Streptozyme® 460502018-09-24
10859035006030IMPACT RPR™ TEST KIT (50 TESTS)60C1 2016-09-24
10859035006047IMPACT RPR™ TEST KIT (150 TESTS)60C22016-09-24
10859035006054IMPACT RPR™ TEST KIT (500 TESTS)60C32016-09-24
10859035006061IMPACT RPR™ TEST KIT (5000 TESTS)60C42016-09-24
10859035006078IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS)60C62016-09-24
10859035006085IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML61C02016-09-24
10859035006092IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML61C12016-09-24
10859035006108IMPACT RPR™ DRY CONTROL CARDS 10 EA61C22016-09-24
10859035006115IMPACT RPR™ LIQUID CONTROL 3 X 1 ML61C32016-09-24
10859035006122IMPACT RPR™ PIPETS/STIRRERS 500 EA61C42016-09-24
10859035006139IMPACT RPR™ 10 WELL TEST CARDS 300 EA61C52016-09-24
10859035006146IMPACT RPR™ 30 WELL TEST CARDS 100 EA61C72016-09-24
10859035006153IMPACT RPR™ NEEDLE/SHEATH 10 EA61C82016-09-24
10859035006160IMPACT RPR™ DISPENSING BOTTLES 10 EA61C92016-09-24
10859035006177IMPACT RPR™ PIPETS/STIRRERS 250 EA62C42016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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