Identity
- Trade Name
- Alkaline Phosphatase Reagent Set FDA UDI
- Generic Name
- Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Serum alkaline phosphatase estimations are of interest in the diagnosis of two groups of conditions; hepatobiliary disease and bone disease associated with increased osteoblastic activity. FDA UDI
- Model / Reference
- R1 x 500 mL, R2 x 125 mL FDA UDI
- Description
- For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Serum alkaline phosphatase estimations are of interest in the diagnosis of two groups of conditions; hepatobiliary disease and bone disease associated with increased osteoblastic activity. FDA UDI
Identifiers
- Catalog Number
- 501-398 FDA UDI
- Primary DI / UDI-DI
- 00812137011855 FDA UDI
- FDA Product Code
- CJE FDA UDI
- GMDN Term
- Alkaline phosphatase (ALP) isoenzyme 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
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, kit, spectrophotometry
Alkaline Phosphatase Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI b24e0990-607f-44ab-94bc-3a4141f08826 36 fields · synced May 30, 2026