Identity
- Trade Name
- Fluoro-CheckTM Vitamin D FDA UDI
- Generic Name
- Multiple form 25-hydroxy vitamin D IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen. FDA UDI
- Model / Reference
- TF8148 FDA UDI
- Description
- An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen. FDA UDI
Identifiers
- Catalog Number
- TF8148 FDA UDI
- Primary DI / UDI-DI
- 00895160002601 FDA UDI
- FDA Product Code
- MRG FDA UDI
- GMDN Term
- Multiple form 25-hydroxy vitamin D IVD, kit, rapid ICT, clinical 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
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
Yes
FDA UDI
Category: Multiple form 25-hydroxy vitamin D IVD, kit, rapid ICT, clinical
Fluoro-CheckTM Vitamin D by Nano-Ditech Corporation — 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
- Nano-Ditech Corporation
Sources (1)
- FDA UDI 6e59cc69-d909-4cb5-944b-78878cebd88f 35 fields · synced Jun 9, 2026