Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Igg, Antigen, Antiserum, Control

FDA product code DEW · 76 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5510
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-19 – 2005-02-08

DEW 2005-02-08

TINA-QUANT IGG GEN.2

Applicant Roche Diagnostics Corp.

K number K050113

View details →

DEW 2004-03-10

ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2

Applicant Roche Diagnostics Corp.

K number K040434

View details →

DEW 2001-03-15

SPIFE IFE CALIBRATOR AND CONTROL KIT

Applicant Helena Laboratories

K number K010617

View details →

DEW 2000-01-18

WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD

Applicant Wako Chemicals USA, Inc.

K number K993928

View details →

DEW 1999-11-09

K-ASSAY IGG

Applicant Kamiya Biomedical Co.

K number K993281

View details →

DEW 1998-11-04

IGG

Applicant Abbott Laboratories

K number K983221

View details →

DEW 1997-03-06

SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT

Applicant Beckman Instruments, Inc.

K number K965108

View details →

DEW 1997-03-06

IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN

Applicant Beckman Instruments, Inc.

K number K963974

View details →

DEW 1997-02-10

IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)

Applicant Beckman Instruments, Inc.

K number K963868

View details →

DEW 1996-09-26

QUANTEX IGG

Applicant Instrumentation Laboratory CO

K number K962202

View details →

DEW 1996-04-05

IGG IMMUNOTURBIDIMETRIC & CALIBRATOR

Applicant Randox Laboratories, Ltd.

K number K955798

View details →

DEW 1995-05-15

BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL

Applicant Beckman Instruments, Inc.

K number K951635

View details →

DEW 1994-10-03

BEHRING NEPHELOMETER II

Applicant Behring Diagnostics, Inc.

K number K943997

View details →

DEW 1994-04-21

OT IGG SORBENT

Applicant Organon Teknika Corp.

K number K934324

View details →

DEW 1993-09-08

RADIAS FERRITIN ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K933314

View details →

DEW 1992-12-15

ZORBA(TM) IGG REMOVAL REAGENT

Applicant Zeus Scientific, Inc.

K number K924197

View details →

DEW 1992-05-28

IGG SUCLASS EIA

Applicant Virotech Diagnostika

K number K921575

View details →

DEW 1991-06-12

ELISA COMBI-KIT HUMAN IGG SUBCLASSES

Applicant Janssen Research Foundation

K number K911610

View details →

DEW 1990-04-26

MODIFIED TECHNICON DPA-1(TM) SYSTEM

Applicant Technicon Instruments Corp.

K number K900943

View details →

DEW 1989-08-03

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

Applicant Coulter Immunology

K number K893419

View details →

DEW 1989-04-18

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)

Applicant Vitek Systems, Inc.

K number K891385

View details →

DEW 1989-02-22

SPQ(TM) ANTIBODY REAGENT SET II FOR IGG

Applicant Atlantic Antibodies

K number K890416

View details →

DEW 1988-07-12

ACCRAASSAY RID KITS

Applicant Icn Immunobiologicals

K number K882369

View details →

DEW 1988-07-08

QM300 IGG ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K882083

View details →

DEW 1988-06-06

WAKO(TM) IGG-HA DIRECT

Applicant Wako Chemicals USA, Inc.

K number K880784

View details →

DEW 1988-02-17

GULLSORB IGG INACTIVATION REAGENT

Applicant Gull Laboratories, Inc.

K number K875254

View details →

DEW 1988-02-10

IMMUNOGLOBULIN G & G SUBCLASSES

Applicant Birmingham

K number K875356

View details →

DEW 1987-10-13

IMMUNOGLOBULINS G

Applicant Unipath , Ltd.

K number K873870

View details →

DEW 1987-08-12

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K872800

View details →

DEW 1987-04-22

PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS

Applicant Helena Laboratories

K number K871352

View details →

DEW 1987-04-22

QM300 IGG ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K871340

View details →

DEW 1986-09-03

TINA-QUANT(R) IGG

Applicant Boehringer Mannheim Corp.

K number K862764

View details →

DEW 1986-08-25

DAKO ITA SYSTEM

Applicant Dako Corp.

K number K861059

View details →

DEW 1985-09-16

GILFORD IMMUNOGLOBULIN G REAGENT

Applicant Gilford

K number K853465

View details →

DEW 1985-07-15

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K852589

View details →

DEW 1985-07-15

DART IMMUNOGLOBULINS REAGENT SYSTEM

Applicant Coulter Electronics, Inc.

K number K851541

View details →

DEW 1985-03-01

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

Applicant Applications Lab

K number K850583

View details →

DEW 1984-08-02

AMER. HISTO-ID SYS PRIMARY IGG S7920-11

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K842329

View details →

DEW 1984-06-22

OPTIMATE IGG TEST

Applicant Miles Laboratories, Inc.

K number K841816

View details →

DEW 1984-01-24

TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN

Applicant Technicon Instruments Corp.

K number K833402

View details →

DEW 1983-10-31

GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC

Applicant Gelco Diagnostics, Inc.

K number K832258

View details →

DEW 1983-10-28

FITC GOAT ANTI-HUMAN IGG Y CHAIN

Applicant Gelco Diagnostics, Inc.

K number K832264

View details →

DEW 1983-04-27

TIA-IGG REAGENT & CALIBRATOR SETS

Applicant Worthington Diagnostic Systems

K number K831101

View details →

DEW 1983-03-24

TITAN IMMUNO-FIX

Applicant Helena Laboratories

K number K830594

View details →

DEW 1982-04-29

ANTIHUMAN IGG GLOBULIN FITC LABELED

Applicant Microbiological Research Corp.

K number K821018

View details →

DEW 1982-02-10

DAKO PAP KIT K505

Applicant Dako Corp.

K number K812484

View details →

DEW 1981-10-02

ACA IMMUNOGLOBULIN G ANALYTICAL TEST

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K812664

View details →

DEW 1981-09-29

ACA IMMUNOGLOBULIN G CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K812630

View details →

DEW 1981-09-23

IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA

Applicant Dako Corp.

K number K812495

View details →

DEW 1981-09-23

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG

Applicant Dako Corp.

K number K812489

View details →

DEW 1981-09-23

SCRIPPSYSTEM IMMUNOGLOBIN RID KIT

Applicant Scripps-Miles, Inc.

K number K812453

View details →

DEW 1981-09-08

SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT

Applicant Scripps-Miles, Inc.

K number K812328

View details →

DEW 1981-07-23

PHADEBAS IGG RAST TEST

Applicant Pharmacia, Inc.

K number K810694

View details →

DEW 1981-05-08

AIM SYSTEM (FOR IGG)

Applicant Icl Scientific

K number K811126

View details →

DEW 1981-02-09

IMMUNOLOGY CONTROL SERUM

Applicant Icl Scientific

K number K810056

View details →

DEW 1980-10-31

GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC

Applicant Protos Laboratories

K number K802257

View details →

DEW 1980-06-20

J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI

Applicant J.T. Baker Chemical Co.

K number K801281

View details →

DEW 1980-05-08

RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.

Applicant Icl Scientific

K number K800897

View details →

DEW 1980-04-24

GEMENI IGG ASSAY

Applicant Electro-Nucleonics Laboratories, Inc.

K number K800451

View details →

DEW 1980-03-12

PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT

Applicant Diagnostica, Inc.

K number K800398

View details →

DEW 1980-02-05

IMMUNOGLOBULIN G REAGENT SYSTEM

Applicant Calbiochem-Behring Corp.

K number K800119

View details →

DEW 1979-11-27

ANTI-HUMAN IGG SERUM

Applicant Diagnostica, Inc.

K number K791281

View details →

DEW 1979-10-17

ANTISERUM TO HUMAN IMMUNOGLOBULINS

Applicant Icl Scientific

K number K791824

View details →

DEW 1979-10-17

LANCER L-INA ANTI-IGG

Applicant Sherwood Medical Co.

K number K791403

View details →

DEW 1979-10-17

ANTI-HUMAN GLOBULINS

Applicant Diagnostica, Inc.

K number K791285

View details →

DEW 1979-09-04

ANTISERUM, HUMAN, IGG H & L CHAIN

Applicant Kent Laboratories, Inc.

K number K790702

View details →

DEW 1979-04-12

ANTISERUM TO HUMAN IGG

Applicant Kent Laboratories, Inc.

K number K790704

View details →

DEW 1978-02-03

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G

Applicant Gelman Instrument Co.

K number K772077

View details →

DEW 1977-12-22

IMMUNOGLOBULIN G NEPHEL. ASSAY

Applicant Kallestad Laboratories, Inc.

K number K772252

View details →

DEW 1977-06-24

GOAT ANTISERUM IGG NEPHELOMETRIC

Applicant Kallestad Laboratories, Inc.

K number K770961

View details →

DEW 1977-04-28

RHODAMINE-CONJUGATED ANTISERUM

Applicant Kent Laboratories, Inc.

K number K770669

View details →

DEW 1977-04-28

FLUORESCEIN CONJUGATED ANTISERUM

Applicant Kent Laboratories, Inc.

K number K770668

View details →

DEW 1977-04-28

DASP TM ANTI-RABBIT

Applicant Organon, Inc.

K number K770597

View details →

DEW 1977-04-07

ULTRA LOW LEVEL IMMUNOGLOBULIN G

Applicant Intl. Diagnostic Technology

K number K761224

View details →

DEW 1977-03-21

FLUOR. CONJUGATED ANTISERUM

Applicant Kent Laboratories, Inc.

K number K770484

View details →

DEW 1976-07-19

SERUM, IGG GOAT ANTI-HUMAN ACID

Applicant Oxford Laboratories, Inc.

K number K760145

View details →

↑