Identity
- Trade Name
- POINTE SCIENTIFIC BUN FDA UDI
- Generic Name
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 12-B7552-150 FDA UDI
- Description
- For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 12-B7552-150 FDA UDI
- Primary DI / UDI-DI
- 00811727013439 FDA UDI
- 510(k) Number
- K972671 FDA UDI
- FDA Product Code
- CDQ FDA UDI
- GMDN Term
- Urea IVD, kit, enzyme spectrophotometry 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
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: Urea IVD, kit, enzyme spectrophotometry
Pointe Scientific Bun by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, kit, enzyme spectrophotometry.
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- Urea Nitrogen (BUN) Test — STANBIO LABORATORY, L.P. · Class II
- Dimension® Flex® reagent cartridge BUN — Siemens Healthcare Diagnostics · Class II
- UREA UV SL — VITALSCIENTIFIC
- Yumizen C1200 Uric acid — Horiba Abx · Class I
- UreaBUN — Roche Diagnostics Corp. · Class II
- Dimension Vista® Flex® reagent cartridge BUN — Siemens Healthcare Diagnostics · Class II
- Kinetic UV assay for ureaurea nitrogen — Roche Diagnostics Corp. · 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 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 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI bfa6c6b3-d3f7-40e1-bc52-c6c34f7d4b26 37 fields · synced May 30, 2026