Identity
- Trade Name
- Pointe Fentanyl (Qualitative) Reagent Set FDA UDI
- Generic Name
- Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Fentanyl (Qualitative) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Fentanyl Reagent Set is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-FN0620-1L FDA UDI
- Description
- Pointe Fentanyl (Qualitative) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Fentanyl Reagent Set is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-FN0620-1L FDA UDI
- Primary DI / UDI-DI
- 00811727016416 FDA UDI
- 510(k) Number
- K181159 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fentanyl IVD, kit, enzyme immunoassay (EIA)
Pointe Fentanyl (Qualitative) Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 7c9718d2-c98e-47c2-9d5a-a0d84589d2ee 37 fields · synced Jun 8, 2026