Product code GNM— Microbiology
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
- Classification name
- Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
- Device class
- Class 1
- Regulation
- 21 CFR 866.3145
- Advisory panel
- Microbiology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code GNM
FDA has cleared devices under product code GNM, all in 1995, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code GNM
Recent clearances under product code GNM
- K936073 — ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS
- K936089 — COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
- K936145 — COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY
- K936251 — COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
- K936252 — COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
- K936253 — COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
- K936254 — COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
- K940471 — COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES
- K940472 — COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY
Data sourced from openFDA. This site is unofficial and independent of the FDA.