FDA.reportPublic FDA data

RF

Primary DI
05055273205046
Brand
RF
Company
RANDOX LABORATORIES LIMITED
Model
RF2716
Catalog number
RF2716
Device description
The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum.
Published
2016-09-16
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961169000RHEUMATOID FACTOR LATEX SLIDE TEST KITRandox Laboratories, Ltd.1996-06-26DHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273205046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273205046050552732050465055273205046

GMDN Terms#

Term, Definition table
TermDefinition
Rheumatoid factor IVD, kit, nephelometry/turbidimetryA 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 a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The reagents must be allowed to reach room temperature before use. Do not freeze any of the reagents.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
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
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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