Identity
- Trade Name
- 1,25 Dihydroxy Vitamin D RIA FDA UDI
- Generic Name
- 1,25-Dihydroxy vitamin D3 IVD, kit, liquid chromatography FDA UDI
- Model / Reference
- AA-54F1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690011 FDA UDI
- 510(k) Number
- K042519 FDA UDI
- FDA Product Code
- MRG FDA UDI
- GMDN Term
- 1,25-Dihydroxy vitamin D3 IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1825 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: 1,25-Dihydroxy vitamin D3 IVD, kit, liquid chromatography
1, 25 Dihydroxy Vitamin D RIA by Immunodiagnostic Systems , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Immunodiagnostic Systems , Ltd.
Sources (1)
- FDA UDI 3cbd3d28-f155-4dc9-b9de-bd2c09915d58 35 fields · synced May 30, 2026