NZS · Class I · 21 CFR 866.2660

FDA Product Code NZS: Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast

Indicated As A Qualitative Nucleic Acid Hybridization Assay Intended For Identification Of Candida Albicans From Blood Cultures With Yeast.

Leading manufacturers include Advandx, Inc..

3
Total
3
Cleared
205d
Avg days
2010
Since

FDA 510(k) Cleared Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast Devices (Product Code NZS)

3 devices
1–3 of 3
Cleared Jul 15, 2010
YEAST TRAFFIC LIGHT PNA FISH
K093024
Advandx, Inc.
Microbiology · 289d
Cleared Mar 12, 2010
C. ALBICANS/C. GLABRATA PNA FISH
K092784
Advandx, Inc.
Microbiology · 183d
Cleared Jan 19, 2010
C. ALBICANS PNA FISH
K092655
Advandx, Inc.
Microbiology · 144d

About Product Code NZS - Regulatory Context