FDA product code DFZ: Igg (Gamma Chain Specific), Antigen, Antiserum, Control
DFZ is the FDA product code for igg (gamma chain specific), antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 9 510(k) submissions under DFZ, from 7 different applicants. The average 510(k) review took 77 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Igg (Gamma Chain Specific), Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DFZ clearance
Top DFZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 2 | 2002-06-17 |
| Kent Laboratories, Inc. | 2 | 1979-08-16 |
| Siemens Healthcare Diagnostics | 1 | 2009-10-21 |
| Sanquin Blood Supply Foundation | 1 | 2002-05-14 |
| Boehringer Mannheim Corp. | 1 | 1996-02-09 |
2 more applicants have DFZ clearances. See the full list in Caduvo.
Most recent DFZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092283 | Siemens Healthcare Diagnostics | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | 2009-10-21 | 84 |
| K021081 | The Binding Site, Ltd. | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | 2002-06-17 | 75 |
| K020823 | Sanquin Blood Supply Foundation | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | 2002-05-14 | 61 |
| K955906 | Boehringer Mannheim Corp. | BOEHRINGER MANNHEIM IGG ASSAY | 1996-02-09 | 42 |
| K940422 | The Binding Site, Ltd. | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER | 1994-05-27 | 128 |
Recalls for DFZ devices
openFDA lists no recalls for product code DFZ.
Frequently asked questions
What is FDA product code DFZ?
DFZ is the FDA product code for igg (gamma chain specific), antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is DFZ?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFZ?
Across 9 cleared submissions the average was 77 days from receipt to decision (median 75).
Which companies have the most DFZ clearances?
The Binding Site, Ltd. (2); Kent Laboratories, Inc. (2); Siemens Healthcare Diagnostics (1); Sanquin Blood Supply Foundation (1); Boehringer Mannheim Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DFZ
- Run a recall and safety report across every DFZ manufacturer
- Watch product code DFZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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