Identity
- Trade Name
- ALP FDA UDI
- Generic Name
- Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI
- Device Name
- The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of Alkaline Phosphatase (ALP) activity in serum or plasma. FDA UDI
- Model / Reference
- AP2809 FDA UDI
- Description
- The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of Alkaline Phosphatase (ALP) activity in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- AP2809 FDA UDI
- Primary DI / UDI-DI
- 05055273200300 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 9052fb8a-2b79-4917-83a9-8013c08d867e 37 fields · synced May 30, 2026