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System, Test, Rheumatoid Factor

FDA product code DHR · 143 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5775
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-03 – 2020-05-20

DHR 1985-06-05

LASER RF CONTROL SERUM-QUALITY CONTROL SERUM

Applicant Behring Diagnostics, Inc.

K number K851537

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DHR 1985-04-25

IGM RHEUMATOID FACTOR TEST KIT

Applicant Breit Laboratories, Inc.

K number K851099

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DHR 1985-04-12

LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS

Applicant Behring Diagnostics, Inc.

K number K850296

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DHR 1985-03-01

ABBOTT RF EIA DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K850373

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DHR 1984-10-25

RHEUMADX LATEX AGGLUTINATION RHEUMATOID

Applicant Diagnostic Products Corp.

K number K843896

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DHR 1984-04-25

RF TEST KIT

Applicant Difco Laboratories, Inc.

K number K841454

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DHR 1984-04-20

NCS RA LATEX TEST

Applicant Ncs Diagnostics, Inc.

K number K841146

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DHR 1984-04-04

SERATEST RF LATEX DETERMINATION

Applicant Seragen Diagnostics, Inc.

K number K840863

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DHR 1984-02-13

NABI RF-Q.S. TEST

Applicant Intl. Diagnostic, Inc.

K number K840005

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DHR 1984-02-10

SOPHEIA MP IGM RHEUMATOID FACTOR EIA

Applicant Diagnostic Products Corp.

K number K840049

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DHR 1984-02-03

IMMUNO-RA

Applicant Immunostics Co., Inc.

K number K834391

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DHR 1983-07-18

LEAP RHEUMATOID FACTOR TEST KIT

Applicant Cooper Diagnostics, Inc.

K number K831941

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DHR 1983-06-30

SERO/TEX RED CELL RF TEST

Applicant Texas Immunology, Inc.

K number K831597

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DHR 1983-06-08

RA-CHECK

Applicant Diagnostic Technology, Inc.

K number K831467

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DHR 1983-04-18

RHEUMATOID FACTOR-RAPID CARD TEST #65114

Applicant Emd Chemicals, Inc.

K number K830832

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DHR 1983-03-24

RA SCREENING TEST

Applicant Tago, Inc.

K number K830611

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DHR 1982-10-18

LATEST RF KIT FOR RHEUMATOID FACTOR

Applicant Fisher Scientific Co., LLC

K number K822905

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DHR 1982-08-27

RHEUMATOID FACTOR REFERENCE PREPARA.

Applicant Armkel, LLC

K number K821941

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DHR 1982-05-21

SERO/TEX RF TEST

Applicant Texas Immunology, Inc.

K number K821319

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DHR 1981-12-17

RA-80 POSITIVE CONTROL

Applicant Sun-Kit

K number K813309

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DHR 1981-11-06

RA LATEX TEST

Applicant Oxoid U.S.A., Inc.

K number K812972

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DHR 1981-11-06

FIAX RHEUMATOID FACTOR TEST KIT

Applicant Intl. Diagnostic Technology

K number K812968

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DHR 1981-10-26

RHEUMATEX

Applicant Armkel, LLC

K number K812882

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DHR 1981-06-12

BI-RA SLIDE TEST

Applicant Biologics Intl., Inc.

K number K811375

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DHR 1981-03-11

RHEUMATOID FACTORS REFERENCE SERUM

Applicant Calbiochem-Behring Corp.

K number K810404

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DHR 1981-03-11

RHEUMATOID FACTOR REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K number K810306

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DHR 1981-02-09

SCRIPPSERA THEUMATOID FACTOR REFER. CNTL

Applicant Scripps-Miles, Inc.

K number K810221

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DHR 1981-02-09

SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT

Applicant Scripps-Miles, Inc.

K number K810141

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DHR 1981-01-05

RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.

Applicant Syn-Kit, Inc.

K number K802448

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DHR 1980-12-18

RHEUMATOID FACTOR TEST SYSTEMS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K802688

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DHR 1980-10-10

RF-II TEST KIT

Applicant Immuno-Diagnostic Products, Inc.

K number K801961

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DHR 1980-02-21

AUTOMATED RHEMATOID FACTOR TEST (ARFT)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K800268

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DHR 1980-01-24

NORMAL GLOBULIN REAGENT

Applicant Meridian Diagnostics, Inc.

K number K792697

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DHR 1980-01-24

ANTI-GLOBULIN CONTROL

Applicant Meridian Diagnostics, Inc.

K number K792695

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DHR 1979-12-31

AGGLUTINOTEST-RHEUMATOID ARTHRITIS

Applicant Volu Sol Medical Industries

K number K791507

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DHR 1979-11-27

CORDIA RF

Applicant Cordis Corp.

K number K792061

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DHR 1979-03-15

RHEUMATELL

Applicant Central Biological Co.

K number K790351

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DHR 1979-01-26

RHEUMOGEN TEST SYSTEM

Applicant Calbiochem-Behring Corp.

K number K790012

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DHR 1977-11-02

QUANTROLS RF

Applicant Organon, Inc.

K number K771940

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DHR 1977-09-02

RHEUMANOSTICON R

Applicant Organon, Inc.

K number K771410

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DHR 1977-08-30

LAS-R RHEUMATOID FACTOR TEST

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K771552

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DHR 1976-08-03

TEST, RHEUM. ARTH., CARD (MACRO-VUE)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K760043

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DHR 1976-08-03

TEST, LATEX SLIDE, RHEUMATOID FACTOR

Applicant Gamma Biologicals, Inc.

K number K760036

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