FDA.reportPublic FDA data

K-ASSAY® RF Calibrator

Primary DI
00816426020429
Brand
K-ASSAY® RF Calibrator
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-032C
Catalog number
KAI-032C
Device description
For the calibration of the K-ASSAY® RF assay.
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K991467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991467000K-ASSAY RHEUMATOID FACTOR CALIBRATOR SETKamiya Biomedical Co.1999-06-10DHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020429008164260204298164260204290816426020429

GMDN Terms#

Term, Definition table
TermDefinition
Rheumatoid factor IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
206-575-8068diagnostics@k-assay.com

Regulatory Flags#

DUNS number
197934250
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
00816426020894K-ASSAY® Plasma ControlK81C-6MK81C-6M2016-09-16
00816426020924K-ASSAY® Coagulation ControlK104C-10MK104C-10M2016-09-16
00816426021013K-ASSAY® Coagulation ControlK204C-10MK204C-10M2016-09-16
00816426021099K-ASSAY® Factor XIII ControlK135C-10MK135C-10M2017-02-09
00816426021129K-ASSAY® Factor XIII ControlK204C-10MK204C-10M2017-02-09
00816426021266K-ASSAY® D-Dimer ControlK92C-2MK92C-2M2018-05-30
00816426021273K-ASSAY® D-Dimer ControlK92C-4MK92C-4M2018-05-30
00816426021600K-ASSAY® Cystatin C CalibratorKAI-200CKAI-200C2026-04-16
00816426021617K-ASSAY® Cystatin C ControlK200C-2MK200C-2M2026-04-16
00816426021594K-ASSAY® UIBC ReagentKAI-305KAI-3052026-03-13
00816426021549K-ASSAY® CRP Reagent (Ver.2)KAI-375KAI-3752026-02-27
00816426021556K-ASSAY® CRP Calibrator (Ver.2)KAI-376CKAI-376C2026-02-27
00816426020146K-ASSAY® Alpha-1 AG ReagentKAI-021KAI-0212016-09-16
00816426020375K-ASSAY® Total IgE ReagentKAI-092KAI-0922016-09-16
00816426020672K-ASSAY® Total IgE CalibratorKAI-093CKAI-093C2016-09-16
00816426021389K-ASSAY® Total IgE ControlK94C-4MK94C-4M2019-01-25
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAI-400CKAI-400C2024-04-17
00816426020641K-ASSAY® CRP (3) Calibrator FKAI-086CKAI-086C2016-09-16
00816426020269K-ASSAY® Fructosamine Reagent + Calibrator (L)KAI-050KAI-0502016-09-16
00816426021402K-ASSAY® UIBC Reagent (L)KAI-301KAI-3012019-04-09

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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
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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