Product code CZP
- Device name
- Iga, 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 |
|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | 2020-06-26 |
| K060130 | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | Beckman Coulter, Inc. | 2006-02-13 |
| K040435 | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 | Roche Diagnostics Corp. | 2004-03-10 |
| K024038 | N LATEX IGA | Dade Behring, Inc. | 2003-02-13 |
| K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | Wako Chemicals USA, Inc. | 2000-01-14 |
| K983359 | IGA | Abbott Laboratories | 1998-11-04 |
| K962200 | QUANTEX IGA | Instrumentation Laboratory CO | 1996-09-25 |
| K955794 | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 |
| K955907 | BOEHRINGER MANNHEIM IGA ASSAY | Boehringer Mannheim Corp. | 1996-02-09 |
| K952309 | N LATEX IGA | Behring Diagnostics, Inc. | 1995-06-20 |
| K931806 | IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1993-07-16 |
| K920014 | IL TEST IMMUNOGLOBULIN A | Instrumentation Laboratory CO | 1992-06-16 |
| K900422 | TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 | Helena Laboratories | 1990-02-27 |
| K894418 | RAICHEM(TM) SPIA(TM) IGA REAGENTS | Reagents Applications, Inc. | 1989-08-02 |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Atlantic Antibodies | 1989-02-15 |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Orion Diagnostica, Inc. | 1988-10-19 |
| K883492 | TECHNICON DPA-1 IMMUNOGLOBULIN A | Technicon Instruments Corp. | 1988-09-22 |
| K880803 | WAKO(TM) IGA-HA DIRECT | Wako Chemicals USA, Inc. | 1988-03-29 |
| K873869 | IMMUNOGLOBULINS A | Unipath , Ltd. | 1987-10-13 |
| K871940 | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-06-12 |
| K863352 | PRECIMAT (R) IGA, G, M | Boehringer Mannheim Corp. | 1986-09-17 |
| K862763 | TINA-QUANT(R) IGA | Boehringer Mannheim Corp. | 1986-09-04 |
| K855046 | TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT | Abbott Laboratories | 1986-08-27 |
| K862183 | DAKO ITA, IMMUNOGLOBULIN A (IGA) | Dako Corp. | 1986-08-19 |
| K861167 | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST | Atlantic Antibodies | 1986-04-25 |
| K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 |
| K853467 | GILFORD IMMUNOGLOBULIN A REAGENT | Gilford | 1985-09-16 |
| K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM | Cooper Biomedical, Inc. | 1985-06-11 |
| K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A | Applications Lab | 1985-03-01 |
| K843614 | CORNING IMMUNOFIXATION SYS | Corning Medical & Scientific | 1984-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05700572001140 | Poly Rb A-Hu IgA | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2022-01-27 |
| 00380740171711 | Alinity | ABBOTT IRELAND | 2021-04-29 |
| 00380740171704 | ARCHITECT | ABBOTT IRELAND | 2021-04-02 |
| 00380740175177 | ARCHITECT | Abbott GmbH | 2020-11-06 |
| 03610230007334 | Yumizen C1200 Immunoglobulin A | HORIBA ABX SAS | 2020-07-13 |
| 00630414285030 | N Latex IgA | Siemens Healthcare Diagnostics Products GmbH | 2020-06-23 |
| 07613336121313 | Tina-quant IgA Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740153915 | Alinity | Abbott GmbH | 2020-01-01 |
| 00842768007200 | N Latex IgA | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 05055273203905 | IgA | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05055273203899 | IgA | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05055273203882 | IgA | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| B1761020 | Antiserum to Human IgA (alpha chain specific) | KENT LABORATORIES INC | 2016-09-24 |
| 05051700010375 | Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 04015630919666 | Tinaquant IgA Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630925728 | Tinaquant IgA Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630919680 | Tinaquant IgA Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630913411 | Immunoglobulin A | Roche Diagnostics GmbH | 2016-09-20 |
| 05055273203820 | IgA | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05700572000860 | Poly Rb A-Hu IgA, IgG, IgM | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| 05700572000617 | Poly Rb A-Hu IgA | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| 00380740000493 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740019754 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |