← Back to catalogue
Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method) FDA UDI
- Generic Name
- Total alkaline phosphatase (ALP) IVD, reagent FDA UDI
- Device Name
- The Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method) is used for the direct colorimetric determination of alkaline phosphatase in human serum. FDA UDI
- Model / Reference
- A506-140 FDA UDI
- Description
- The Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method) is used for the direct colorimetric determination of alkaline phosphatase in human serum. FDA UDI
Identifiers
- Catalog Number
- A506-140 FDA UDI
- Primary DI / UDI-DI
- 10673486001075 FDA UDI
- 510(k) Number
- K880177 FDA UDI
- FDA Product Code
- CIO FDA UDI
- GMDN Term
- Total alkaline phosphatase (ALP) 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
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, reagent
Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method) by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total alkaline phosphatase (ALP) IVD, reagent.
- Alkaline phosphatase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Alkaline Phosphatase acc to IFCC Gen2 — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Alkaline phosphatase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 4bd96318-18cd-4b9e-ae0f-0a749acd1012 37 fields · synced May 30, 2026