Product code DFZ
- Device name
- Igg (Gamma Chain Specific), 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 |
|---|---|---|---|
| K092283 | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | Siemens Healthcare Diagnostics | 2009-10-21 |
| K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | The Binding Site, Ltd. | 2002-06-17 |
| K020823 | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | Sanquin Blood Supply Foundation | 2002-05-14 |
| K955906 | BOEHRINGER MANNHEIM IGG ASSAY | Boehringer Mannheim Corp. | 1996-02-09 |
| K940422 | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER | The Binding Site, Ltd. | 1994-05-27 |
| K812821 | H-103 IGG, H-104 IGA, H-105 IGM | Immulok, Inc. | 1981-10-26 |
| K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | Icl Scientific | 1981-01-26 |
| K790709 | ANTISERUM TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | 1979-08-16 |
| K790720 | ANTISERA TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | 1979-08-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700006064 | Hu IgG Subclass Liquid Reagent Kits for use on Hitachi 911/912/917 and Modular P | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700007597 | Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700007696 | Human IgG2 Subclass Hitachi Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00842768006265 | DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006272 | DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006289 | DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006296 | DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |