Identity
- Trade Name
- Dimension® Flex® reagent cartridge ALPI FDA UDI
- Generic Name
- Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Alkaline Phosphatase Flex® reagent cartridge, 360 tests FDA UDI
- Model / Reference
- 10642445 FDA UDI
- Description
- Alkaline Phosphatase Flex® reagent cartridge, 360 tests FDA UDI
Identifiers
- Catalog Number
- DF150 FDA UDI
- Primary DI / UDI-DI
- 00842768039010 FDA UDI
- 510(k) Number
- K121907 FDA UDI
- FDA Product Code
- CJO 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Dimension® Flex® reagent cartridge ALPI by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry.
- Alkaline phosphatase acc. to IFCC Gen.2 — Roche Diagnostics Corp. · Class II
- ENVOY 500 ALP REAGENT KIT — VITALSCIENTIFIC
- Pointe Alkaline Phosphatase Reagent — POINTE SCIENTIFIC, INC. · Class II
- Pointe Alkaline Phosphatase on the BS480 — POINTE SCIENTIFIC, INC. · Class II
- Alkaline Phosphatase LiquiColor® — STANBIO LABORATORY, L.P. · Class II
- POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. Alkaline Phosphatase — POINTE SCIENTIFIC, INC.
- ALP Reagent Kit — Medica Corp. · Class II
Cleared under the same submission
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI ef0a6792-9798-452e-b4a0-6a1916417e18 37 fields · synced May 30, 2026