Identity
- Trade Name
- Pointe Buprenorphine Reagent Set FDA UDI
- Generic Name
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Buprenorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Buprenorphine Reagent Set is intended for the qualitative and semi-quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine at a cutoff value of 5 ng/mL and 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-BP0540-100 FDA UDI
- Description
- Pointe Buprenorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Buprenorphine Reagent Set is intended for the qualitative and semi-quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine at a cutoff value of 5 ng/mL and 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-BP0540-100 FDA UDI
- Primary DI / UDI-DI
- 00811727016300 FDA UDI
- 510(k) Number
- K090844 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Buprenorphine 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: Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Pointe Buprenorphine 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
K090844 also covers:
- Pointe Buprenorphine Reagent Set — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine Cutoff Calibrator #2 (10 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine High Calibrator (75 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine Intermediate Calibrator #1 (20 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine Intermediate Calibrator #2 (40 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine Level 1 Control (3 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine Level 1/Level 2 Control (7 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine Level 2 Control (13 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Norbuprenorphine Low/Cutoff Calibrator (5 ng/mL) — POINTE SCIENTIFIC, INC.
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 621d50ae-6517-4414-b966-7b5aaf1b58c2 37 fields · synced May 31, 2026