Product code CZP— Immunology
N LATEX IGA
- Classification name
- Iga, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 54
- First cleared
- Most recent
Market context for product code CZP
FDA has cleared devices under product code CZP between 1976 and 2020, filed by 40 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
last 15 years- 2020
- 2006
- 2004
- 2003
- 2000
- 1998
- 1996
- 1995
- 1993
- 1992
- 1990
- 1989
- 1988
- 1987
- 1986
Top applicants under product code CZP
Recent clearances under product code CZP
- K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
- K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
- K024038 — N LATEX IGA
- K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
- K983359 — IGA
- K962200 — QUANTEX IGA
- K955794 — IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
- K955907 — BOEHRINGER MANNHEIM IGA ASSAY
- K952309 — N LATEX IGA
- K931806 — IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
- K920014 — IL TEST IMMUNOGLOBULIN A
- K900422 — TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
- K894418 — RAICHEM(TM) SPIA(TM) IGA REAGENTS
- K890560 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
- K884040 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
- K883492 — TECHNICON DPA-1 IMMUNOGLOBULIN A
- K880803 — WAKO(TM) IGA-HA DIRECT
- K873869 — IMMUNOGLOBULINS A
- K871940 — QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
- K863352 — PRECIMAT (R) IGA, G, M
- K862763 — TINA-QUANT(R) IGA
- K855046 — TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
- K862183 — DAKO ITA, IMMUNOGLOBULIN A (IGA)
- K861167 — IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
- K855009 — QUANTIMETRIC PLUS IGA REAGENT KIT
- K853467 — GILFORD IMMUNOGLOBULIN A REAGENT
- K851284 — RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
- K850582 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A
- K843614 — CORNING IMMUNOFIXATION SYS
- K842468 — TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
- K842330 — AMER. HISTO-ID SYS PRIMARY IGA 2720-21
- K832263 — FITC GOAT ANTI-HUMAN IGA A CHAIN
- K831102 — TIA-IGA REAGENT & CALIBRATOR SETS
- K823566 — IMMUNOGLOBULIN CONTROL
- K823567 — IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM
- K822026 — IMMUNO DIAGNOSTICS ASSAY
- K812631 — ACA IMMUNOGLOBIN A TEST PACK
- K812633 — ACA IMMUNOGLOBULIN A/M CALIBRATORS
- K812488 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA
- K812253 — GELMAN IG-FIX KIT
- K811125 — AIM SYSTEM (FOR IGA)
- K803274 — AUTOMATED IMMUNOPRECIPITIN METHOD/IGA
- K801283 — J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
- K800449 — GEMENI IGA ASSAY
- K800211 — IMMUNOGLOBULIN A REAGENT SYSTEM
- K791401 — LANCER L-INA ANTI-IGA
- K790703 — ANTISERUM, HUMAN, IGA
- K790479 — A-GENT IMMUNOGLOBULINE TEST SYSTEM
- K772076 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.
- K772251 — IMMUNOGLOBULIN A NEPHEL. ASSAY
- K771603 — IMMOCHEMISTRY SYSTEM
- K770962 — GOAT ANTISERUM IGA NEPHELOMETRIC
- K760146 — SERUM, IGA GOAT ANTI-HUMAN ACID
Data sourced from openFDA. This site is unofficial and independent of the FDA.