Product code DDG— Immunology
TINA-QUANT TRANSFERRIN VER.2
- Classification name
- Transferrin, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5880
- Advisory panel
- Immunology
- Total cleared
- 48
- First cleared
- Most recent
Market context for product code DDG
FDA has cleared devices under product code DDG between 1977 and 2024, filed by 34 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- 2024
- 2020
- 2018
- 2013
- 2008
- 2007
- 2006
- 2004
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1993
Top applicants under product code DDG
Recent clearances under product code DDG
- K240987 — Access sTfR
- K190495 — Transferrin
- K182095 — Tina-quant Transferrin ver.2 (urine application)
- K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS
- K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
- K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
- K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
- K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C
- K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
- K063322 — DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
- K053075 — N ANTISERA TO HUMAN TRANSFERRIN
- K042477 — VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN
- K012371 — TINA-QUANT TRANSFERRIN VER.2
- K012393 — TINA-QUANT TRANSFERRIN VER.2
- K011662 — MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
- K003064 — TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
- K002585 — RANDOX TRANSFERRIN
- K994294 — DIMENSION TRNF FLEX REAGENT CARTRIDGE
- K993537 — K-ASSAY TRANSFERRIN
- K993162 — WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
- K991157 — N LATEX STFR REAGENT
- K983880 — TRANSFERRIN SPQ III ANTIBODY REAGENT SET
- K983167 — TRF
- K972840 — N ANTISERUM TO HUMAN TRANSFERRIN
- K971958 — SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
- K964295 — N-ASSAY TIA TRANSFERRIN TEST KIT
- K963976 — IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
- K963427 — IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
- K933589 — BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
- K926272 — BECKMAN TRANSFERRIN KIT
- K914993 — IL TEST(TM) TRANSFERRIN (TRF)
- K914390 — TRANSFERRIN RID KIT
- K900875 — RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
- K890563 — SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
- K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
- K873867 — TRANSFERRIN
- K873789 — QM300 TRANSFERRIN ANTIBODY PACK
- K871896 — TINA-QUANT [A] TRANSFERRIN
- K871022 — PRECIMAT(R) TRANSFERRIN
- K854416 — TDX TRANSFERRIN DIAGNOSTIC KIT
- K851287 — RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
- K850589 — SPQ TEST SYSTEM FOR TRANSFERRIN
- K830911 — RADIAL IMMUNODIFFUSION PLATES
- K813288 — NEIA TRANSFERRIN ENZYMEIMMUNOASSAY
- K812492 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN
- K811613 — 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
- K801434 — J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
- K772253 — TRANSFERRIN NEPHELOMETRIC ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.