Identity
- Trade Name
- Pointe Norfentanyl Level 2 Control (6.25 ng/mL) FDA UDI
- Generic Name
- Fentanyl IVD, control FDA UDI
- Device Name
- Pointe Norfentanyl Level 2 Control (6.25 ng/mL) 1 x 5 mL The Pointe Norfentanyl Controls are for use as assayed quality control materials to monitor the precision of the Pointe Fentanyl Reagent Set (Ref# 60-FN0620-100/60-FN0620-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-NF0636-5 FDA UDI
- Description
- Pointe Norfentanyl Level 2 Control (6.25 ng/mL) 1 x 5 mL The Pointe Norfentanyl Controls are for use as assayed quality control materials to monitor the precision of the Pointe Fentanyl Reagent Set (Ref# 60-FN0620-100/60-FN0620-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-NF0636-5 FDA UDI
- Primary DI / UDI-DI
- 00811727016447 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Fentanyl IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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
Yes
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, control
Pointe Norfentanyl Level 2 Control (6.25 ng/mL) by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI e21e976f-b25e-40f3-9201-b2e24d363de2 36 fields · synced May 30, 2026