Product code NBT— Immunology
AESKULISA ASCA A
- Classification name
- Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5785
- Advisory panel
- Immunology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code NBT
FDA has cleared devices under product code NBT between 2000 and 2007, filed by 6 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
- 2007
- 2006
- 2005
- 2004
- 2001
- 2000
Top applicants under product code NBT
Recent clearances under product code NBT
- K071711 — ASCA-CHEK
- K051927 — TECHLAB ASCA-CHEK
- K051492 — AESKULISA ASCA A
- K042579 — BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
- K032850 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
- K032860 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
- K000733 — QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
- DEN000007 — QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.