Identity
- Trade Name
- ALP FDA UDI
- Generic Name
- Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI
- Device Name
- An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma. FDA UDI
- Model / Reference
- AP3877 FDA UDI
- Description
- An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- AP3877 FDA UDI
- Primary DI / UDI-DI
- 05055273200362 FDA UDI
- 510(k) Number
- K923507 FDA UDI
- FDA Product Code
- CJE FDA UDI
- GMDN Term
- Alkaline phosphatase (ALP) isoenzyme IVD, reagent 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
Yes
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: Alkaline phosphatase (ALP) isoenzyme IVD, reagent
Alp by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alkaline phosphatase (ALP) isoenzyme IVD, reagent.
- Thermo Scientific — Fisher Diagnostics · Class II
- TITAN GEL Alkaline Phosphatase Kit — Helena Laboratories, Corp. · Class II
- ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) — CLEARCHEM DIAGNOSTICS INC. · Class II
- SPIFE ALP Separation Enhancer — Helena Laboratories, Corp. · Class II
- SPIFE Alkaline Phosphatase-20, 40 Gel Kit — Helena Laboratories, Corp. · Class II
- ALKALINE PHOSPHATASE — STERLING DIAGNOSTICS INC
- SPIFE Alkaline Phosphatase Reagent Kit — Helena Laboratories, Corp. · Class II
- TITAN GEL Alkaline Phosphatase Reagent Kit — Helena Laboratories, Corp. · Class II
Cleared under the same submission
K923507 also covers:
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI fd424c9c-da1f-4907-b2ed-6348014d9262 37 fields · synced Jun 8, 2026