FDA.reportPublic FDA data

RF LATEX Test Kit

Primary DI
B224R201
Brand
RF LATEX Test Kit
Company
CENOGENICS CORPORATION
Model
R-20
Catalog number
R-20
Device description
Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum.Kit Contains:5 ml RF Latex Reagent10 ml Glycine-Saline Buffer Concentrate1 ml RF Positive Control1 ml RF Negative Control6-ring slideProduct Instructions
Published
2021-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
B224R201PrimaryHIBCC0

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068288943
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B224SB191TRI-SLIDE PATIENT ENVELOPE KITSB-19SB-192021-05-27
B224SB201TRI-SLIDE STOOL BLOOD TESTSB-20SB-202021-05-27
B224SB211PROFESSIONAL SINGLE SLIDE KITSB-21SB-212021-05-27
B224V611VDRL CONTROL SERUM KITV-612021-05-27
B224V551VDRL Antigen KitV-55V-552016-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07333066024134EliA RF IgA WellPhadia ABDHR2026-01-29
00850054026941QMedix™Diagnostic Automation, Inc.DHR2025-03-27
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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
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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
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
00404847435856Rheumatoid Factor IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungDHR2019-06-10