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510(k) Data Aggregation
K Number
K243064Device Name
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
Manufacturer
Eterbio, Inc.
Date Cleared
2024-11-20
(54 days)
Product Code
NGL
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Eterbio, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ETERBIO Fentany]Norfentary] Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
| Drug (Identifier) | Calibrator | Cut-off Level |
|--------------------|-------------|---------------|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method.
The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
| Drug (Identifier) | Calibrator | Cut-off Level |
|--------------------|-------------|---------------|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.
Device Description
Rapid Test ETERBIO Fentanyl/Norfentanyl Gold) and ETERBIO The Fentanyl/Norfentanyl Home Test are immunoassays intended for the qualitative detection of fentanyl and norfentanyl in human urine. Each ETERBIO fentanyl/norfentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.
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