← Back to catalogue
Vit D Direct AccuLite CLIA Test System - 192 wells
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Vit D Direct AccuLite CLIA Test System - 192 wells FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 9475-300 FDA UDI
Identifiers
- Catalog Number
- 9475-300B FDA UDI
- Primary DI / UDI-DI
- 00816870023373 FDA UDI
- FDA Product Code
- MRG FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)
Vit D Direct AccuLite CLIA Test System - 192 wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA).
- 25OH Vitamin D Total ELISA — American Laboratory Products Company · Class II
- 25 OH Vitamin D Total (90') ELISA — DRG International, Inc. · Class II
- 25 OH Vitamin D Total (90') ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Diazyme — Diazyme Laboratories, Inc.
- 25-OH Vitamin D ELISA — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- 25OH Vitamin D Total — Diasource Immunoassays, S.A. · Class II
- Vit D Direct AccuLite CLIA Test System - 480 wells — MONOBIND, INC. · Class II
- Vit D Direct AccuBind ELISA Test System - 480 wells — MONOBIND, INC. · 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
- Monobind, Inc.
Sources (1)
- FDA UDI 6646b04d-04d6-4643-a350-8545bd73f4b7 36 fields · synced May 30, 2026