Identity
- Trade Name
- Pointe Scientific FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- BUN reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- HB952-654 FDA UDI
- Description
- BUN reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- HB952-654 FDA UDI
- Primary DI / UDI-DI
- 00811727012951 FDA UDI
- 510(k) Number
- K972671 FDA UDI
- FDA Product Code
- CDQ FDA UDI
- GMDN Term
- Urea IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1770 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
No
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: Urea IVD, reagent
Pointe Scientific by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, reagent.
- Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) — TECO DIAGNOSTICS · Class II
- Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
- Teco Diagnostics Urea Nitrogen (BUN) Reagent Set — TECO DIAGNOSTICS · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
- UREA — Randox Laboratories, Ltd. · Class II
- ARCHITECT — Abbott · Class II
- ARCHITECT — Abbott · Class II
Cleared under the same submission
K972671 also covers:
- BUN/BS200 — Medtest DX
- BUN/BS480 — Medtest DX
- BUN/Polychem 180 — Medtest DX
- POINTE SCIENTIFIC BUN — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC.
- Pointe BUN Reagent — POINTE SCIENTIFIC, INC.
- Pointe BUN on BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — 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 ec68d86d-a9b9-4c2f-8e1b-886a86c62534 37 fields · synced Jun 8, 2026