Product code DEM— Immunology
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
- Classification name
- Alpha-1-Antitrypsin, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Total cleared
- 30
- First cleared
- Most recent
Market context for product code DEM
FDA has cleared devices under product code DEM between 1976 and 2013, filed by 23 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- 2013
- 2007
- 2006
- 2005
- 2003
- 2001
- 1999
- 1998
- 1997
- 1994
- 1992
- 1991
- 1989
- 1988
- 1985
Top applicants under product code DEM
Recent clearances under product code DEM
- K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
- K063610 — DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K053072 — N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
- K052819 — VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
- K050596 — QUANTIA A1-AT
- K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
- K011663 — MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
- K010978 — TINA-QUANT ALPHA-1 ANTITRYPSIN
- K993444 — K-ASSAY ALPHA-1 AT
- K972640 — TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
- K973389 — CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
- K973390 — CHEMMATE L26 (CD20)
- K973391 — CHEMMATE KAPPA
- K973392 — CHEMMATE LAMBDA
- K965100 — N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
- K964766 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
- K931979 — VENTANA NEGATIVE CONTROL REAGENT
- K920005 — IL TEST ALPHA-1-ANTITRYPSIN (AAT)
- K913666 — ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT
- K890415 — SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
- K882446 — ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
- K875281 — QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
- K875283 — QM2/QM300 CONTROL B PACK
- K850587 — SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
- K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
- K791605 — GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN
- K781408 — RID SYSTEM-(ACP) TEST
- K772080 — RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT
- K760916 — LAS-R HUMAN ALPHA, ANTITRYPSIN TEST
- K760034 — TEST, STREP, LATEX SLIDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.