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Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
PMN · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3920
Classification
- FDA Product Code
PMN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.3920
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Market data
- Cleared 510(k) submissions
- 30
- Registered establishments
- 10
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown