Product code NGS— Microbiology
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
- Classification name
- Assay, Endotoxin Activity, Chemiluminescent
- Device class
- Class 2
- Regulation
- 21 CFR 866.3210
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code NGS
FDA has cleared devices under product code NGS between 2003 and 2019, filed by 2 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
- 2019
- 2003
Top applicants under product code NGS
Recent clearances under product code NGS
Data sourced from openFDA. This site is unofficial and independent of the FDA.