← FDA Medical Device Classifications
Gram-Negative Bacteria And Associated Resistance Markers
PEN · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3365
Classification
- FDA Product Code
PEN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.3365
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Market data
- Cleared 510(k) submissions
- 11
- Registered establishments
- 4
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown