Identity
- Trade Name
- Pointe Scientific, Inc. Alkaline Phosphatase FDA UDI
- Generic Name
- Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Packaged with barcodes for use on AU400, AU480 and AU640. 5 x 50ml, 4 x 13ml. FDA UDI
- Model / Reference
- OA902-702 FDA UDI
- Description
- Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Packaged with barcodes for use on AU400, AU480 and AU640. 5 x 50ml, 4 x 13ml. FDA UDI
Identifiers
- Catalog Number
- OA902-702 FDA UDI
- Primary DI / UDI-DI
- 00811727014900 FDA UDI
- 510(k) Number
- K973588 FDA UDI
- GMDN Term
- Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry FDA UDI
Classification
- 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. Alkaline Phosphatase by Pointe Scientific, Inc. — 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. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 0d814bd6-cffc-4d67-bd2c-1b567dafcab6 37 fields · synced Jun 8, 2026