Product code DER— Immunology
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
- Classification name
- Alpha-1-Lipoprotein, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5580
- Advisory panel
- Immunology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code DER
FDA has cleared devices under product code DER between 1981 and 2001, filed by 11 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
- 2001
- 2000
- 1999
- 1997
- 1991
- 1990
- 1987
- 1986
- 1985
- 1984
- 1981
Top applicants under product code DER
Recent clearances under product code DER
- K013249 — TINA-QUANT APOLIPOPROTEIN VER.2
- K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3
- K993354 — K-ASSAY APO B
- K993345 — K-ASSAY APO AI
- K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
- K983289 — APOLIPOPROTEIN A1
- K964292 — N-ASSAY TIA APO A1 TEST KIT
- K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR
- K964296 — N-ASSAY TIA APO B TEST KIT
- K910553 — ROCHE APOLIPOPROTEIN STANDARD
- K904125 — UC IMU A
- K872078 — QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
- K854875 — APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1
- K853048 — APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
- K851649 — APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
- K840830 — VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
- K802610 — ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.