Product code DBF— Immunology
FERRITIN RIA KIT
- Classification name
- Ferritin, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Total cleared
- 87
- First cleared
- Most recent
Market context for product code DBF
FDA has cleared devices under product code DBF between 1977 and 2021, filed by 62 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- 2021
- 2020
- 2017
- 2014
- 2012
- 2011
- 2010
- 2009
- 2006
- 2005
- 2004
- 2003
- 2002
- 2000
- 1999
Top applicants under product code DBF
Recent clearances under product code DBF
- K193650 — LIAISON Ferritin
- K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
- K171642 — Atellica IM Ferritin Assay
- K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
- K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
- K110736 — ADVIA CHEMISTRY FERRITIN (FRT) METHOD
- K100538 — TINA-QUANT FERRITIN GEN. 4
- K092505 — BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
- K062746 — FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
- K053211 — RDI HSFERRITIN KIT
- K052617 — FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,
- K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
- K040879 — QUANTEX FERRITIN
- K031650 — FERRITIN GENERATION 2
- K030124 — OLYMPUS FERRITIN REAGENT
- K014293 — K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
- K000662 — RANDOX FERRITIN
- K993273 — N LATEX FERRITIN
- K992517 — BIOCHECK FERRITIN ELISA MODEL BC-1025
- K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
- K984186 — NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
- K983340 — IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
- K983759 — ABBOTT ARCHITECT FERRITIN
- K982714 — BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
- K974505 — AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
- K973331 — VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
- K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM
- K970612 — SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
- K963170 — OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
- K951993 — UBI MAGIWEL FERRITIN QUANTITATIVE
- K952286 — AMERLITE FERRITIN II ASSAY
- K950707 — N LATEX FERRITIN
- K935847 — AXSYM FERRITIN
- K935528 — DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
- K931576 — VISTA FERRITIN ASSAY
- K924858 — AIA-PACK FER CALIBRATION VERIFICATION TEST SET
- K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
- K920046 — MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
- K911175 — SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
- K905770 — CIBA CORNING ACS FERRITIN IMMUNOASSAY
- K904822 — ELEGANCE FERRITIN ELISA
- K901075 — LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
- K896585 — MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
- K895872 — LAN.0800Q/2800Q
- K892362 — AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
- K885074 — AFFINITY(TM) FERRITIN IMMUNIT(TM)
- K884683 — FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
- K883746 — MICROMEDIC FERRITIN IRMA KIT
- K874203 — AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
- K874572 — ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
- K874031 — IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
- K873573 — CIBA CORNING MAGIC LITE FERRITIN
- K871489 — DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
- K870570 — FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
- K870107 — COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS
- K864437 — BECKMAN EPSILON(TM) FERRITIN TEST KIT
- K863345 — TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
- K863487 — QUANTIMUNE(R) FERRITIN IRMA
- K862960 — PHASE II FERRITIN RADIOIMMUNOASSAY KIT
- K862014 — IMMPULSE FERRITIN ASSAY REAGENT
- K860137 — ENZYMUN-TEST FERRITIN
- K844158 — STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
- K841925 — DSL FERRITIN IRMA
- K830580 — DIAGNON FERRITIN 125 I RIA KIT
- K830591 — CORNING FERRITIN 125I RADIOIMMUNOASSAY
- K823871 — TANDEM-E -FER IMMUNOENZYMETRIC KIT
- K823275 — AUTOPAK FERRITIN TEST DELIVERY SYS
- K822472 — ANTISERA TO HUMAN FERRITIN
- K812901 — 125I FERRITIN RADIOIMMUNOASSAY KIT
- K812786 — FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS
- K812597 — FERRITIN KIT
- K812056 — SPECTRO FEIRITIN
- K811880 — LEECO FERRITIN-QUANT DIAG. TEST KIT
- K811804 — FERRITIN RIA KIT
- K811808 — AUTOPAK-12 FERRITIN KIT
- K801989 — NORDICLAB FERRITIN IRMA TEST
- K801676 — FERRIZYME FERRITIN ENZYME IMMUNOASSAY
- K801580 — FERRITIN RIA KIT
- K800657 — FERRITIN CONTROLS CODE QAS.104
- K800299 — FERRITIN RIA KIT
- K792449 — CENTRIA FERRITIN RIA
- K792442 — FERRITIN RADIOIMMUNOASSAY
- K791860 — FERRITIN RIA KIT
- K790447 — VENTRE/SEP FERRITIN RIA
- K790490 — NEIA-FERRITIN ENZYMEIMMUNASSAY KIT
- K780490 — NEIA-FERRITIN ENZYMEIMMUNOASSAY
- K770702 — IN VITRO FERRITIN RIA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.