Identity
- Trade Name
- Pointe Scientific Inc. FDA UDI
- Generic Name
- Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 4 x 100ml, 4 x 23ml FDA UDI
- Model / Reference
- HA916-492 FDA UDI
- Description
- Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 4 x 100ml, 4 x 23ml FDA UDI
Identifiers
- Catalog Number
- HA916-492 FDA UDI
- Primary DI / UDI-DI
- 00811727012531 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 Scientific Inc. 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 Alkaline Phosphatase on the BS480 — 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 da8cbc9f-ac7f-4714-901f-74b10f116b96 37 fields · synced Jun 1, 2026