Product code DEW
- Device name
- Igg, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5510
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050113 | TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | 2005-02-08 |
| K040434 | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | 2004-03-10 |
| K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT | Helena Laboratories | 2001-03-15 |
| K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | 2000-01-18 |
| K993281 | K-ASSAY IGG | Kamiya Biomedical Co. | 1999-11-09 |
| K983221 | IGG | Abbott Laboratories | 1998-11-04 |
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | Beckman Instruments, Inc. | 1997-03-06 |
| K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | Beckman Instruments, Inc. | 1997-03-06 |
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | Beckman Instruments, Inc. | 1997-02-10 |
| K962202 | QUANTEX IGG | Instrumentation Laboratory CO | 1996-09-26 |
| K955798 | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 |
| K951635 | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL | Beckman Instruments, Inc. | 1995-05-15 |
| K943997 | BEHRING NEPHELOMETER II | Behring Diagnostics, Inc. | 1994-10-03 |
| K934324 | OT IGG SORBENT | Organon Teknika Corp. | 1994-04-21 |
| K933314 | RADIAS FERRITIN ENZYME IMMUNOASSAY | Bio-Rad | 1993-09-08 |
| K924197 | ZORBA(TM) IGG REMOVAL REAGENT | Zeus Scientific, Inc. | 1992-12-15 |
| K921575 | IGG SUCLASS EIA | Virotech Diagnostika | 1992-05-28 |
| K911610 | ELISA COMBI-KIT HUMAN IGG SUBCLASSES | Janssen Research Foundation | 1991-06-12 |
| K900943 | MODIFIED TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1990-04-26 |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Coulter Immunology | 1989-08-03 |
| K891385 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) | Vitek Systems, Inc. | 1989-04-18 |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | Atlantic Antibodies | 1989-02-22 |
| K882369 | ACCRAASSAY RID KITS | Icn Immunobiologicals | 1988-07-12 |
| K882083 | QM300 IGG ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-07-08 |
| K880784 | WAKO(TM) IGG-HA DIRECT | Wako Chemicals USA, Inc. | 1988-06-06 |
| K875254 | GULLSORB IGG INACTIVATION REAGENT | Gull Laboratories, Inc. | 1988-02-17 |
| K875356 | IMMUNOGLOBULIN G & G SUBCLASSES | Birmingham | 1988-02-10 |
| K873870 | IMMUNOGLOBULINS G | Unipath , Ltd. | 1987-10-13 |
| K872800 | TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT | Abbott Laboratories | 1987-08-12 |
| K871340 | QM300 IGG ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-04-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740169893 | Alinity | ABBOTT IRELAND | 2021-04-29 |
| 00380740169909 | ARCHITECT | ABBOTT IRELAND | 2021-04-02 |
| 00380740175184 | ARCHITECT | Abbott GmbH | 2020-11-06 |
| 00630414002903 | BN II System | Siemens Healthcare Diagnostics Products GmbH | 2020-09-24 |
| 03610230007358 | Yumizen C1200 Immunoglobulin G | HORIBA ABX SAS | 2020-07-13 |
| 07613336121320 | Tina-quant IgG Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740153922 | Alinity | Abbott GmbH | 2019-12-24 |
| 03573026619527 | VIDAS® PC SOFTWARE V4.9 | BIOMERIEUX SA | 2019-12-20 |
| 05055273203967 | IgG | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 05051700010368 | Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05055273203974 | IgG | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05051700010399 | Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010443 | Human IgG - ‘NL’ BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010917 | Human IgG1 Subclass Single Dilution BINDARID™ Kits | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010924 | Human IgG2 Subclass Single Dilution BINDARID™ Kits | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010931 | Human IgG3 Subclass Single Dilution BINDARID™ Kits | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010948 | Human IgG3 Subclass Single Dilution BINDARID™ Kits | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05055273203936 | IgG | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05055273203950 | IgG | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| B1761010 | Antiserum to Human IgG (gamma chain specific) | KENT LABORATORIES INC | 2016-09-24 |
| 00840733101304 | MERIFLUOR GullSORB | MERIDIAN BIOSCIENCE, INC. | 2016-09-23 |
| 04015630925735 | Tinaquant IgG Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630919710 | Tinaquant IgG Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630919697 | Tinaquant IgG Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630913923 | IGG Immunoglobulin G Turbidimetric) | Roche Diagnostics GmbH | 2016-09-20 |
| 03573026152482 | VIDAS® | BIOMERIEUX SA | 2016-09-14 |
| 03573026140427 | VIDAS® | BIOMERIEUX SA | 2016-09-14 |
| 15099590233372 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590231620 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590231613 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |