Product code NBS— Immunology
EUROIMMUN ANTI-LKM-1 ELISA(LGG)
- Classification name
- Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code NBS
FDA has cleared devices under product code NBS between 2000 and 2017, 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
- 2017
- 2012
- 2000
Top applicants under product code NBS
Recent clearances under product code NBS
Data sourced from openFDA. This site is unofficial and independent of the FDA.