Product code DFZ— Immunology
ANTISERA TO RABBIT IMMUNOGLOBULIN
- Classification name
- Igg (Gamma Chain Specific), Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code DFZ
FDA has cleared devices under product code DFZ between 1979 and 2009, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2009
- 2002
- 1996
- 1994
- 1981
- 1979
Top applicants under product code DFZ
Recent clearances under product code DFZ
- K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
- K021081 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
- K020823 — PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
- K955906 — BOEHRINGER MANNHEIM IGG ASSAY
- K940422 — IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
- K812821 — H-103 IGG, H-104 IGA, H-105 IGM
- K803272 — AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
- K790709 — ANTISERUM TO RABBIT IMMUNOGLOBULIN
- K790720 — ANTISERA TO RABBIT IMMUNOGLOBULIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.