Identity
- Trade Name
- Pointe Alkaline Phosphatase on the BS480 FDA UDI
- Generic Name
- Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline phosphatase in human serum on the BS480 Analyzer.. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 14-A7516-225 FDA UDI
- Description
- Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline phosphatase in human serum on the BS480 Analyzer.. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 14-A7516-225 FDA UDI
- Primary DI / UDI-DI
- 00811727015709 FDA UDI
- 510(k) Number
- K973588 FDA UDI
- FDA Product Code
- CJE FDA UDI
- GMDN Term
- Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1050 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: Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Pointe Alkaline Phosphatase on the BS480 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
K973588 also covers:
- Alk Phos R1 (w/ssa#) — POINTE SCIENTIFIC, INC.
- Alk Phos R1 (w/ssa#) — POINTE SCIENTIFIC, INC.
- Alk Phos R2 (w/ssa#) — POINTE SCIENTIFIC, INC.
- Alk Phos R2 (w/ssa#) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Alkaline Phosphatase — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) — POINTE SCIENTIFIC, INC.
- Pointe Alkaline Phosphatase Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Alkaline Phosphatase — 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 207d2be5-2988-4a2e-b4a6-7324f7e8d718 37 fields · synced May 30, 2026