NBT · Class II · 21 CFR 866.5785

FDA Product Code NBT: Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)

Leading manufacturers include Inova Diagnostics, Inc., Immco Diagnostics, Inc. and The Binding Site.

8
Total
7
Cleared
215d
Avg days
2000
Since

FDA 510(k) Cleared Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) Devices (Product Code NBT)

8 devices
1–8 of 8
Cleared Nov 07, 2007
ASCA-CHEK
K071711
Techlab Inc., Corporate Research Center
Immunology · 138d
Cleared Apr 06, 2006
TECHLAB ASCA-CHEK
K051927
Techlab, Inc.
Immunology · 262d
Cleared Nov 14, 2005
AESKULISA ASCA A
K051492
Aesku, Inc.
Immunology · 161d
Cleared Jul 28, 2005
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
K042579
The Binding Site
Immunology · 309d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850
Immco Diagnostics, Inc.
Immunology · 188d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860
Immco Diagnostics, Inc.
Immunology · 188d
Cleared May 21, 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
K000733
Inova Diagnostics, Inc.
Immunology · 441d
Not Cleared Aug 16, 2000
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
DEN000007
Inova Diagnostics, Inc.
Immunology · 29d

About Product Code NBT - Regulatory Context