FDA.reportPublic FDA data

Teco Diagnostics Rheumatoid Factor (RF) Reagent Set

Primary DI
10673486002423
Brand
Teco Diagnostics Rheumatoid Factor (RF) Reagent Set
Company
TECO DIAGNOSTICS
Model
RF-100
Catalog number
RF-100
Device description
Teco Diagnostics Rheumatoid Factor (RF) Reagent Set is for the qualitative and semi-quantitative measurement of RF in human serum.
Published
2024-04-01
Public version status
New
Distribution status
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
K962015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962015000RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TESTTeco Diagnostics1996-11-25DHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486002423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600242310673486002423

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

Contacts#

Phone, Email table
PhoneEmail
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
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10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MATRIX-160TC-MATRIX-1602025-05-28
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10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestP596-25P596-252024-12-19

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Primary DI, Brand, Company table
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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
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